PINNACLE Hip SolutionsRecalls & reported problems across all models
Depuy (Ireland) · 10 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 216
- Deaths reported
- 0
- Injuries reported
- 207
- Recalls
- 0
We found 10 models of PINNACLE Hip Solutions by Depuy (Ireland) in the FDA's device registry (GUDID). Together they are named in 216 adverse event reports in the FDA's MAUDE database, received between Feb 15, 2021 and Sep 29, 2026 — classified as 207 injuries, 9 malfunctions.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (78 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 Hip Solutions problems
Device problems
- Adverse Event Without Identified Device or Use Problem125
- Device Dislodged or Dislocated78
- Off-Label Use7
- Difficult to Insert6
- Improper or Incorrect Procedure or Method3
- Naturally Worn3
- Device Contaminated During Manufacture or Shipping1
- Tear, Rip or Hole in Device Packaging1
Patient problems
- Unspecified Infection85
- Joint Dislocation74
- Pain32
- Joint Laxity19
- Fluid Discharge6
- Insufficient Information6
- No Clinical Signs, Symptoms or Conditions6
- Fall5
PINNACLE Hip Solutions models
10 models, most reported first. Each model has its own page with its reports, recalls and device details.
- PINNACLE Hip Solutions 1218-54-047Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented47 reports
- PINNACLE Hip Solutions 1218-56-049PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED35 reports
- PINNACLE Hip Solutions 1218-50-043Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented33 reports
- PINNACLE Hip Solutions 1218-52-045PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED24 reports
- PINNACLE Hip Solutions 1218-48-041PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED23 reports
- PINNACLE Hip Solutions 1218-58-049PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED20 reports
- PINNACLE Hip Solutions 1218-60-051Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented14 reports
- PINNACLE Hip Solutions 1218-62-053PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED11 reports
- PINNACLE Hip Solutions 1218-64-053Prosthesis, hip, semi-constrained, uncemented, metal / polymer, non-porous, calcium phosphate8 reports
- PINNACLE Hip Solutions 1218-66-055Prosthesis, hip, semi-constrained, uncemented, metal / polymer, non-porous, calcium phosphate1 report
Recent PINNACLE Hip Solutions adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient required revision of hip implants due to post operative infection. DAIR procedure was carried out.
Patient problems: Unspecified Infection
MAUDE report 50931062 ↗InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Unspecified Infection
MAUDE report 50917969 ↗InjurySep 11, 2026Adverse Event Without Identified Device or Use Problem
It was reported that patient was revised due to revision poly exchange for excessive poly wear.DOI: Unknown.DOR: Unknown.Affected side: Left.
Patient problems: Insufficient Information
MAUDE report 50732526 ↗InjurySep 3, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Pain; Unspecified Infection
MAUDE report 50595649 ↗InjurySep 2, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Unspecified Infection
MAUDE report 50569569 ↗InjurySep 1, 2026Adverse Event Without Identified Device or Use Problem
It was reported that due to infection, surgeon chose to replace head and liner.DOI: Unknown ,DOR: (b)(6) 2026 ,Affected Side: Unknown Hip.
Patient problems: Unspecified Infection
MAUDE report 50547091 ↗InjuryJul 29, 2026Device Dislodged or Dislocated
It was reported that dislocating hip.DOI: Unknown.DOR: (b)(6) 2026.Affected Side: Left Hip.
Patient problems: Joint Dislocation
MAUDE report 50077813 ↗InjuryJul 29, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the head and liner were changed for suspected infection, possible metal-on-metal (MoM) reactivity, and a large fibrous fluid collection that was inconclusive with no way to confirm. DOI: (b)(6) 2025.DOR: (b)(6) 2026.Affected side: Right Hip.
Patient problems: Fluid Discharge; Unspecified Infection
MAUDE report 50071694 ↗InjuryJun 17, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO PAIN. DOI: (B)(6) 2026. DOR: (B)(6) 2026. AFFECTED SIDE: UNKNOWN HIP.
Patient problems: Pain
MAUDE report 25531768 ↗InjuryJun 10, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT REMOVAL OF ALL COMPONENTS IN AN INFECTED TOTAL JOINT WITH AN ACETABULAR FRACTURE. LOOSENING INTERFACE WAS MARKED AS NON-CEMENTED. AFFECTED SIDE- LEFT HIP.
Patient problems: Unspecified Infection
MAUDE report 25461498 ↗InjuryJun 10, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT UNDERWENT CONVERSION OF A DUAL MOBILITY TO A PRIMARY LINER AND CERAMIC REVISION HEAD. DOI: UNKNOWN, DOR: (B)(6) 2026, AFFECTED SIDE: RIGHT HIP.
Patient problems: Physical Asymmetry
MAUDE report 25458765 ↗InjuryMay 27, 2026Adverse Event Without Identified Device or Use Problem
PATIENT WAS REVISED DUE TO INFECTION. HEAD AND LINER WERE SWAPPED. AFFECTED SIDE: LEFT KNEE.
Patient problems: Unspecified Infection
MAUDE report 25299714 ↗InjuryApr 23, 2026Device Dislodged or Dislocated
IT WAS REPORTED THAT PATIENT PRESENTED IN OFFICE FOR FOLLOW UP POST DISLOCATION AND PAIN. X-RAYS REVEALED ECCENTRICITY OF THE IMPLANT POST HIP RELOCATION AND THE SURGEON SUSPECTED A HEAD-LINER DISASSOCIATION DURING THE ATTEMPTED RELOCATION. REVISION TOTAL HIP ARTHROPLASTY WAS SCHEDULED, AND INTRAOPERATIVELY, THE POLY LINER WAS FOUND DISASSOCIATED WITH LOOSENING AT THE NON-CEMENTED INTERFACE. BOTH THE LINER AND A WELL-FIXED FEMORAL HEAD WERE REMOVED DUE TO POTENTIAL DAMAGE, ALONG WITH THE METAL DM LINER. NEW COMPONENTS WERE IMPLANTED WITHOUT DELAY OR PATIENT HARM, AND HIP RANGE OF MOTION WAS STABLE POST-PROCEDURE. IT IS BELIEVED THE POLY LINER DISASSOCIATION OCCURRED DURING THE ATTEMPTED RELOCATION, AS PREVIOUS IMAGING SHOWED ALL COMPONENTS WELL FIXED AND FUNCTIONING. DOI: (B)(6) 2025. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT HIP.
Patient problems: Joint Dislocation; Pain
MAUDE report 24971556 ↗InjuryMar 18, 2026Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT HAD A HIP REVISION DONE THE WEEK PRIOR AND THEY DISLOCATED POST OP WHILE STILL IN THE HOSPITAL. SURGEON OBSERVED THE PATIENT FOR A FEW DAYS, AND WHEN THEY DISLOCATED AGAIN, DECIDED TO REVISE. CHANGED OUT THE LINER/HEAD AND WENT WITH A LONGER HEAD; WAS VERY STABLE ON THE OR TABLE. DOI: (B)(6) 2026. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT HIP.
Patient problems: Joint Dislocation
MAUDE report 24630087 ↗InjuryMar 11, 2026Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO RECURRENT DISLOCATION. THEY WERE CONVERTED TO A CONSTRAINED LINER. DOI: (B)(6) 2025, DOR: (B)(6) 2026, AFFECTED SIDE: RIGHT HIP.
Patient problems: Joint Dislocation
MAUDE report 24570397 ↗
Other Depuy (Ireland) products
All Depuy (Ireland) 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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