PINNACLERecalls & reported problems across all models
Depuy Orthopaedics, Inc. · 182 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4,587
- Deaths reported
- 4
- Injuries reported
- 4,335
- Recalls
- 0
We found 182 models of PINNACLE by Depuy Orthopaedics, Inc. in the FDA's device registry (GUDID). Together they are named in 4,587 adverse event reports in the FDA's MAUDE database, received between Jan 31, 2013 and Sep 29, 2026 — classified as 4 deaths, 4,335 injuries, 248 malfunctions.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1,019 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported PINNACLE problems
Device problems
- Adverse Event Without Identified Device or Use Problem1,821
- Device Dislodged or Dislocated1,019
- Loss of Osseointegration552
- Osseointegration Problem453
- Fracture331
- Naturally Worn242
- Insufficient Device Problem Information222
- Loose or Intermittent Connection74
Patient problems
- No Code Available1,425
- Pain1,402
- Unspecified Infection1,129
- Inadequate Osseointegration879
- Joint Dislocation747
- Discomfort409
- Tissue Damage303
- Foreign Body Reaction297
PINNACLE models
182 models, 100 per page, most reported first. Each model has its own page with its reports, recalls and device details.
- PINNACLE 1217-25-500PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED735 reports
- PINNACLE 1217-20-500PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED2 deaths590 reports
- PINNACLE 1217-30-500PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED1 death484 reports
- PINNACLE 1217-35-500PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED315 reports
- PINNACLE 1217-15-500PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED1 death251 reports
- PINNACLE 1217-40-500PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED127 reports
- PINNACLE 1218-28-650Prosthesis, hip, constrained, cemented or uncemented, metal/polymer89 reports
- PINNACLE 1219-32-148PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED77 reports
- PINNACLE 1218-32-652Prosthesis, hip, constrained, cemented or uncemented, metal/polymer75 reports
- PINNACLE 1218-32-654Prosthesis, hip, constrained, cemented or uncemented, metal/polymer70 reports
- PINNACLE 1219-32-150PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED70 reports
- PINNACLE 1217-45-500PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED62 reports
- PINNACLE 1219-32-052PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED59 reports
- PINNACLE 1219-36-152PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED59 reports
- PINNACLE 1218-28-648Prosthesis, hip, constrained, cemented or uncemented, metal/polymer57 reports
- PINNACLE 1219-36-452PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED51 reports
- PINNACLE 1218-32-752Prosthesis, hip, constrained, cemented or uncemented, metal/polymer50 reports
- PINNACLE 1219-32-054PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED49 reports
- PINNACLE 1219-28-146PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED45 reports
- PINNACLE 1218-28-750Prosthesis, hip, constrained, cemented or uncemented, metal/polymer44 reports
- PINNACLE 1219-36-154PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED39 reports
- PINNACLE 1218-36-656Prosthesis, hip, constrained, cemented or uncemented, metal/polymer38 reports
- PINNACLE 1218-36-658Prosthesis, hip, constrained, cemented or uncemented, metal/polymer34 reports
- PINNACLE 1217-50-500PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED33 reports
- PINNACLE 1219-36-056PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED32 reports
- PINNACLE 1219-36-454PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED32 reports
- PINNACLE 1219-32-152PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED31 reports
- PINNACLE 1219-32-450PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED29 reports
- PINNACLE 1217-20-046PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED28 reports
- PINNACLE 1218-32-754Prosthesis, hip, constrained, cemented or uncemented, metal/polymer27 reports
- PINNACLE 1219-32-058PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED27 reports
- PINNACLE 1219-32-252PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED27 reports
- PINNACLE 1219-28-050PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED26 reports
- PINNACLE 1219-36-156PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED25 reports
- PINNACLE 1218-36-660Prosthesis, hip, constrained, cemented or uncemented, metal/polymer23 reports
- PINNACLE 1219-32-056PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED23 reports
- PINNACLE 1219-36-058PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED23 reports
- PINNACLE 1219-36-158PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED23 reports
- PINNACLE 1218-28-748Prosthesis, hip, constrained, cemented or uncemented, metal/polymer22 reports
- PINNACLE 1219-28-048PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED21 reports
- PINNACLE 1218-36-756Prosthesis, hip, constrained, cemented or uncemented, metal/polymer20 reports
- PINNACLE 1218-36-758Prosthesis, hip, constrained, cemented or uncemented, metal/polymer20 reports
- PINNACLE 1217-12-052PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED19 reports
- PINNACLE 1219-36-456PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED19 reports
- PINNACLE 1217-12-054PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED18 reports
- PINNACLE 1219-32-448PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED17 reports
- PINNACLE 1219-28-148PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED16 reports
- PINNACLE 1219-28-250PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED16 reports
- PINNACLE 1219-32-254PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED16 reports
- PINNACLE 1219-28-046Prosthesis, hip, semi-constrained, metal/polymer, cemented13 reports
- PINNACLE 1219-28-052PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED13 reports
- PINNACLE 1219-28-144PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED13 reports
- PINNACLE 1217-55-500PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED12 reports
- PINNACLE 1218-40-662Prosthesis, hip, constrained, cemented or uncemented, metal/polymer12 reports
- PINNACLE 1217-12-050PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED11 reports
- PINNACLE 1218-36-760Prosthesis, hip, constrained, cemented or uncemented, metal/polymer11 reports
- PINNACLE 1219-32-256PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED11 reports
- PINNACLE 1219-36-460PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED11 reports
- PINNACLE 1217-20-044Prosthesis, hip, semi-constrained, metal/polymer, cemented10 reports
- PINNACLE 1218-40-762Prosthesis, hip, constrained, cemented or uncemented, metal/polymer10 reports
- PINNACLE 1217-11-056PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED9 reports
- PINNACLE 1217-12-056PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED9 reports
- PINNACLE 1219-28-150PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED9 reports
- PINNACLE 1219-36-060PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED9 reports
- PINNACLE 1217-11-052PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED8 reports
- PINNACLE 1217-60-500PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED8 reports
- PINNACLE 1218-40-664Prosthesis, hip, constrained, cemented or uncemented, metal/polymer8 reports
- PINNACLE 1219-32-154PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED8 reports
- PINNACLE 1219-32-156PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED8 reports
- PINNACLE 2999-58-770IMPACTOR8 reports
- PINNACLE 1218-32-052PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED7 reports
- PINNACLE 1219-28-054PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED7 reports
- PINNACLE 1219-32-060PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED7 reports
- PINNACLE 1217-11-050PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED6 reports
- PINNACLE 1217-12-048PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED6 reports
- PINNACLE 1217-12-058PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED6 reports
- PINNACLE 1217-12-060PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED6 reports
- PINNACLE 1219-28-056PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED6 reports
- PINNACLE 1219-32-258PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED6 reports
- PINNACLE 1219-32-452PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED6 reports
- PINNACLE 1219-36-062PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED6 reports
- PINNACLE 1219-36-458PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED6 reports
- PINNACLE 1217-11-048PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED5 reports
- PINNACLE 1218-32-656Prosthesis, hip, constrained, cemented or uncemented, metal/polymer5 reports
- PINNACLE 1218-40-764Prosthesis, hip, constrained, cemented or uncemented, metal/polymer5 reports
- PINNACLE 1219-28-154PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED5 reports
- PINNACLE 1219-28-248PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED5 reports
- PINNACLE 1219-32-158PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED5 reports
- PINNACLE 2999-66-321IMPACTOR5 reports
- PINNACLE 1217-08-500PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED4 reports
- PINNACLE 1217-11-054PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED4 reports
- PINNACLE 1218-40-666Prosthesis, hip, constrained, cemented or uncemented, metal/polymer4 reports
- PINNACLE 1219-22-038PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED4 reports
- PINNACLE 1219-28-060PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED4 reports
- PINNACLE 1219-28-252PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED4 reports
- PINNACLE 1219-28-256PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED4 reports
- PINNACLE 1219-28-448PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED4 reports
- PINNACLE 1219-28-450PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED4 reports
- PINNACLE 1219-32-260PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED4 reports
- PINNACLE 1219-32-454PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED4 reports
Recent PINNACLE adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 29, 2026Device Dislodged or Dislocated
It was reported that the patient was revised due to dislocation.Affected side: Left hip.
Patient problems: Joint Dislocation
MAUDE report 50931157 ↗InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Unspecified Infection
MAUDE report 50828429 ↗InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Unspecified Infection
MAUDE report 50825716 ↗InjurySep 16, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient came in with an infected right hip. The patient had all hip implants and placing cement spacer removed. There was no delay in case.DOI- (b)(6)2021.DOR- (b)(6)026.Affected side- Right Hip.
Patient problems: Unspecified Infection
MAUDE report 50791121 ↗InjurySep 15, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient was unstable.DOI: (b)(6) 2024.DOR: (b)(6) 2026.Affected side: Unknown.
Patient problems: Joint Laxity
MAUDE report 50775224 ↗InjurySep 11, 2026Device Dislodged or Dislocated
It was reported the patient had a Corail Stem, a pinnacle cup and a marathon liner. After 8 years, the liner unclipped and slipped so patient had to be revised for a new liner and head for his hip replacement. Revision surgery went well.DOI: 8 years ago .DOE: (b)(6) 2026.
Patient problems: Insufficient Information
MAUDE report 50737288 ↗InjurySep 11, 2026Device Dislodged or Dislocated
It was reported that patient was revision due to dislocation.DOI: Unknown.DOR: (b)(6)2026.Affected Side: Left Hip.
Patient problems: Joint Dislocation
MAUDE report 50734653 ↗MalfunctionSep 10, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50722441 ↗InjurySep 10, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the mode of failure is instability. A revision of the head and liner components was performed in effort to achieve a stable construct.DOI: (b)(6)2019.DOR: (b)(6)2026.Affected side: Unknown.
Patient problems: Joint Laxity
MAUDE report 50720563 ↗InjurySep 10, 2026Device Dislodged or Dislocated
It was reported that patient had dislocation.DOI: (b)(6) 2026.DOR: (b)(6) 2026.Affected side: Left Hip.
Patient problems: Joint Dislocation
MAUDE report 50718007 ↗InjurySep 10, 2026Device Dislodged or Dislocated; Naturally Worn
It was reported that the patient presented acutely at ED on (b)(6) 2026 unable to weight-bear on right side 10 years post THA following a deep flexion movement (no fall). The patient was taken to theatre on (b)(6) 2026 and revision of liner and head was performed. A 56 x 36 lipped ALTRX liner was implanted and a 1.5mm Delta TS head. The surgeon was confident there was no damage to inner surface of cup insitu and decided to leave in place.
Patient problems: Loss of Range of Motion
MAUDE report 50713297 ↗InjurySep 8, 2026Device Dislodged or Dislocated
It was reported that there was a Revision of Pinnacle 32/52 Lipped liner 121732252 390A15. Implanted due to dislocation. Cup was retained and converted to Pinnacle Dual Mobility.
Patient problems: Joint Dislocation
MAUDE report 50673824 ↗InjurySep 8, 2026Device Dislodged or Dislocated
It was reported the patient underwent a revision THR. The Poly Liner disengaged from the Shell and broke into a few pieces. The Cup and Implant Sector Shell were extracted and a new Poly Insert and Screw were added. The Stem was well fixed; the Taper was not damaged and a revision Delta TS Head was used.
Patient problems: Insufficient Information
MAUDE report 50670778 ↗InjuryAug 28, 2026Adverse Event Without Identified Device or Use Problem
It was reported that patient had prostalac spacer for infection, right hip. Removal of all implants from original surgery date of (b)(6) 2026. Affected side- Right Hip.
Patient problems: Unspecified Infection
MAUDE report 50497518 ↗InjuryAug 27, 2026Device Dislodged or Dislocated
It was reported that Patient suffered a dislocation. Dr informed me that the patient would like to perform a head and liner exchange. The patient was already implanted with a DePuy constrained liner and 32 +5 TS ceramic head. Those components were removed. Dr was unsure of when that revision took place or when the original surgery date was. Once those implants were removed, a new constrained liner was opened and implanted. The patient opted to go with a +4 neutral constrained liner this time as opposed to the +4/10 degree. A new TS 32+5 head was implanted and reduced. Stability was confirmed and the closing process began. No delays or adverse events took place.Activity Level - Yes.DOI-Unknown.DOR-(b)(6)2026.Affected side-Right.
Patient problems: Joint Dislocation
MAUDE report 50475775 ↗
Other Depuy Orthopaedics, Inc. products
- PINNACLE ALTRX98 models · 5,631 reports
- BIOLOX DELTA40 models · 4,995 reports · 1 recall
- QUICKSET7 models · 3,790 reports
- PINNACLE POROCOAT38 models · 2,112 reports
- SUMMIT POROCOAT20 models · 1,646 reports
- PINNACLE GRIPTION57 models · 1,608 reports
- DURALOC93 models · 1,262 reports
- SUMMIT53 models · 697 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page