PINNACLE POROCOATRecalls & reported problems across all models
Depuy Orthopaedics, Inc. · 38 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2,112
- Deaths reported
- 4
- Injuries reported
- 1,945
- Recalls
- 0
We found 38 models of PINNACLE POROCOAT by Depuy Orthopaedics, Inc. in the FDA's device registry (GUDID). Together they are named in 2,112 adverse event reports in the FDA's MAUDE database, received between Aug 26, 2013 and Sep 23, 2026 — classified as 4 deaths, 1,945 injuries, 163 malfunctions.
The most frequently reported specific device problem is “Loss of Osseointegration” (307 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 POROCOAT problems
Device problems
- Adverse Event Without Identified Device or Use Problem803
- Loss of Osseointegration307
- Osseointegration Problem205
- Device Dislodged or Dislocated198
- Malposition of Device173
- Use of Device Problem169
- Insufficient Device Problem Information129
- Difficult to Insert71
Patient problems
- Pain949
- No Code Available808
- Unspecified Infection514
- Inadequate Osseointegration475
- Discomfort345
- Foreign Body Reaction286
- Tissue Damage273
- Inflammation169
PINNACLE POROCOAT models
38 models, most reported first. Each model has its own page with its reports, recalls and device details.
- PINNACLE POROCOAT 1217-22-052Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented335 reports
- PINNACLE POROCOAT 1217-22-054Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented263 reports
- PINNACLE POROCOAT 1217-22-050Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented253 reports
- PINNACLE POROCOAT 1217-22-056Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented220 reports
- PINNACLE POROCOAT 1217-22-058Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented3 deaths142 reports
- PINNACLE POROCOAT 1217-22-048Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented104 reports
- PINNACLE POROCOAT 1217-01-052Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented95 reports
- PINNACLE POROCOAT 1217-01-050Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented84 reports
- PINNACLE POROCOAT 1217-01-054Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented82 reports
- PINNACLE POROCOAT 1217-22-060Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented82 reports
- PINNACLE POROCOAT 1217-01-056Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented1 death73 reports
- PINNACLE POROCOAT 1217-03-052PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED56 reports
- PINNACLE POROCOAT 1217-01-058Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented40 reports
- PINNACLE POROCOAT 1217-22-062Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented35 reports
- PINNACLE POROCOAT 1217-01-048Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented30 reports
- PINNACLE POROCOAT 1217-03-050Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented29 reports
- PINNACLE POROCOAT 1217-03-054Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented27 reports
- PINNACLE POROCOAT 1217-03-056Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented22 reports
- PINNACLE POROCOAT 1217-01-060Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented16 reports
- PINNACLE POROCOAT 1217-20-052Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented16 reports
- PINNACLE POROCOAT 1217-20-056Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented13 reports
- PINNACLE POROCOAT 1217-20-050Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented12 reports
- PINNACLE POROCOAT 1217-03-058Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented11 reports
- PINNACLE POROCOAT 1217-22-064Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented10 reports
- PINNACLE POROCOAT 1217-03-048Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented8 reports
- PINNACLE POROCOAT 1217-01-062Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented7 reports
- PINNACLE POROCOAT 1217-20-054Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented7 reports
- PINNACLE POROCOAT 1217-20-058Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented7 reports
- PINNACLE POROCOAT 1217-03-060Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented6 reports
- PINNACLE POROCOAT 1217-03-064Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented5 reports
- PINNACLE POROCOAT 1217-01-064PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED4 reports
- PINNACLE POROCOAT 1217-20-060Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented4 reports
- PINNACLE POROCOAT 1217-20-048Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented3 reports
- PINNACLE POROCOAT 1217-20-062Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented3 reports
- PINNACLE POROCOAT 1217-22-066Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented3 reports
- PINNACLE POROCOAT 1217-03-062Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented2 reports
- PINNACLE POROCOAT 1217-03-066Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented2 reports
- PINNACLE POROCOAT 1217-20-066Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented1 report
Recent PINNACLE POROCOAT adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 23, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient is unstable. The cup and liner were taken out and their position was changed during a revision procedure.DOI: (b)(6) 2010.DOR: (b)(6) 2026.Affected side: Left hip.
Patient problems: Joint Laxity
MAUDE report 50873099 ↗InjurySep 18, 2026Device Dislodged or Dislocated
It was reported the HCP reported to NCA/BfArM: Premature high-grade polyethylene wear with inlay subluxation and direct contact between the ceramic head and metal cup of the right hip joint occurred after implantation of a cement-free fixed total hip joint endoprosthesis in (b)(6) 2023.
Patient problems: Insufficient Information
MAUDE report 50816436 ↗InjurySep 10, 2026Adverse Event Without Identified Device or Use Problem
It was reported a THA revision was performed for a disassociated liner after the patient had fell down while playing pickle ball. The patient was about 3 year post-op on the day of the revision. After exposure and dislocation of the hip, and removal of the femoral head, the surgeon inspected the liner. The liner (Altrx 36/52 +4 / 10 degrees) was not really disassociated but rather had broken into a few pieces. The elevated portion of the liner (the 10 degree lip) had broken off, as well as some of the ARDs.The stem in situ is a Corail KLA size 13. The femoral head had been rubbing directly against the cup for some time, so there was some intra-articular debris. The surgeon opted to remove the cup and upsize to a size 54. He used an Emphasys multi-hole and elevated rim liner. He then used a TS Delta ceramic head size 40+5. The Corail stem was well fixed and remained in situ. The post x-rays were satisfactory and the patient is in good condition.
Patient problems: Fall
MAUDE report 50714410 ↗InjurySep 10, 2026Device Dislodged or Dislocated
It was reported that the patient presented acutely at ED on 17/8/26 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 19/8/26 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 50713383 ↗InjurySep 9, 2026Adverse Event Without Identified Device or Use Problem
It was reported on March 23, 2009, patient had a surgery of total hip arthroplasty indicated for osteoarthritis of the left hip.(b)(6) 2024: Patient is experiencing left knee pain for 3 weeks. Pain is expected to be secondary to left knee osteoarthritis with exacerbation. No implants are currently present in the knee. Patient underwent a left knee injection and arthrocentesis.On (b)(6) 2025, patient was revised due to developing pain in the left hip. Patient has a history of metal-on-metal prosthesis on both sides. Patient had metal ions assessed which unfortunately were significantly elevated. Through the operation, it was identified there was some mildly hemorrhagic bursitis which was carefully debrided. There were some inflamed synovial fronds both anteriorly and posteriorly and these were debrided. There was significant bony overgrowth anteriorly and this was debrided.Patient reports experiencing a sensation of grinding in her hip when bending over to tie her shoe but does not experience any associated pain. Patient recalls an isolated incident of pain on the contralateral side but has not experienced any subsequent discomfort. Patient reports satisfactory progress with her lef
Patient problems: Discomfort; Hemorrhage/Blood Loss/Bleeding; Metal Related Pathology; Pain; Synovitis
MAUDE report 50692180 ↗InjuryAug 31, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient was revised due to prostalac placement for infection. There was a removal of all implants.DOI: (b)(6) 2024.DOR: (b)(6) 2026.Affected side: Left.
Patient problems: Unspecified Infection
MAUDE report 50530855 ↗InjuryAug 31, 2026Noise, Audible
Patient problems: Foreign Body Reaction; Pain; Unspecified Musculoskeletal problem
MAUDE report 50518546 ↗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 50497384 ↗InjuryAug 5, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient was revised due to surgeon suspicion of instability. There was no other information known.DOI: Unknown. DOR: on (b)(6) 2026. Affected side: Left Hip.
Patient problems: Joint Laxity
MAUDE report 50147242 ↗InjuryJul 27, 2026Device Dislodged or Dislocated
It was reported that patient underwent total hip arthroplasty (THA) on (b)(6) 2024. The then presented to the emergency department on (b)(6) 2026, complaining of severe pain in the left hip which had worsened significantly since the previous evening. Weight-bearing on the left leg was barely possible; the patient denied any preceding trauma. The patient had repeatedly noticed a "grinding" or "popping" sensation in the left hip while walking.An earlier consultation on (b)(6) 2026, due to increasing hip discomfort, had revealed no radiological or CT evidence of prosthesis loosening, periprosthetic fracture, or inlay dislocation. At that time, the femoral head appeared properly centered within the acetabular component. Current diagnostic imaging revealed an eccentric position of the prosthetic head within the acetabular component. CT findings raised suspicion of inlay dislocation or a material defect in the hip prosthesis. Additionally, an extensive periprosthetic fluid collection containing air pockets was noted. However, clinical and laboratory findings showed no evidence of an acute infection.Based on these findings, an indication for emergency surgical revision was established. Cu
Patient problems: Discomfort; Pain; Swelling/ Edema
MAUDE report 50045238 ↗InjuryJun 23, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO INFECTION. AFFECTED SIDE: RIGHT HIP.
Patient problems: Unspecified Infection
MAUDE report 25595123 ↗InjuryMay 5, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INFECTION ASSOCIATED WITH PROSTALAC. DOI: UNKNOWN, DOR: (B)(6) 2026, AFFECTED SIDE-LEFT HIP.
Patient problems: Unspecified Infection
MAUDE report 25086573 ↗InjuryApr 30, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THE PATIENT HAD A HISTORY OF A METAL-METAL ARTICULATING TOTAL HIP ARTHROPLASTY OF THE RIGHT HIP. ON (B)(6) 2024, AN MRI OF THE RIGHT HIP REVEALED THE PRESENCE OF FLUID COLLECTION EMANATING FROM THE JOINT. LABORATORY EVALUATION DEMONSTRATED ELEVATED PLASMA METAL ION LEVELS. ON (B)(6) 2026, THE PATIENT UNDERWENT REVISION SURGERY OF THE RIGHT TOTAL HIP ARTHROPLASTY DUE TO MECHANICAL FAILURE SECONDARY TO METAL HYPERSENSITIVITY, RESULTING IN AN ADVERSE LOCAL TISSUE REACTION (ALTR). DOI: (B)(6) 2009 DOR: (B)(6) 2026 AFFECTED SIDE: RIGHT HIP.
Patient problems: Hypersensitivity/Allergic reaction; Metal Related Pathology; Swelling/ Edema; Unspecified Tissue Injury
MAUDE report 25046358 ↗InjuryApr 28, 2026Adverse Event Without Identified Device or Use Problem
InjuryApr 27, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT ON (B)(6) 2010, PATIENT UNDERWENT A TOTAL HIP ARTHROPLASTY DUE TO EHLERS-DANLOS SYNDROME, DYSPLASTIC AND DEGENERATIVE RIGHT HIP. ON (B)(6) 2025, PATIENT UNDERWENT A REVISION, RIGHT TOTAL HIP ARTHROPLASTY DUE TO PAIN, METAL ON METAL WEAR WITH ELEVATED METAL ION LEVELS PRIOR SPINAL FUSION. DOI: (B)(6) 2010, DOR: (B)(6) 2025, AFFECTED SITE: RIGHT HIP. THE RELATED (B)(4) CAPTURES REVISION OF THE LEFT HIP DUE TO ELEVATED IONS AND PERSISTENT PAIN.
Patient problems: Foreign Body Reaction; Metal Related Pathology; Pain
MAUDE report 25006640 ↗
Other Depuy Orthopaedics, Inc. products
All Depuy Orthopaedics, Inc. devices →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.
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