PINNACLE GRIPTION 1217-16-054Recalls & reported problems
Depuy Orthopaedics, Inc. · PINNACLE GRIPTION ACETABULAR SHELL REVISION 54mm OD 48 LINER · Class 2 · Implant
All models of PINNACLE GRIPTION (57)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295009313), received between May 12, 2021 and Oct 18, 2021 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Difficult to Insert” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Difficult to Insert1
- Migration1
- Osseointegration Problem1
Patient problems
- Inadequate Osseointegration1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryOct 18, 2021Osseointegration Problem; Migration; Osseointegration Problem; Migration
THE PATIENT WAS REVISED TO ADDRESS MIGRATION AND LOOSENING OF THE CUP AT THE BONE TO IMPLANT INTERFACE. CANCER PATIENT. CONVERTED TO TRI-FLANGE. PROXIMAL FEMUR AND SEGMENT REMOVED TO RE-ESTABLISH LEG LENGTH. DOI: (B)(6) 2018, DOR: (B)(6) 2021 AFFECTED SIDE: LEFT HIP.
Patient problems: Inadequate Osseointegration
MAUDE report 12646632 ↗MalfunctionMay 12, 2021Difficult to Insert; Difficult to Insert
IT WAS REPORTED THAT THE PDM LINER WOULD NOT STAY SEATED WITH MULTIPLE TRIAL REDUCTIONS, THERE MAY HAVE BEEN TISSUE IN THE VIP TAPER. THE DECISION WAS MADE TO PUT IN ANOTHER PINNACLE POLY LINER. THE BROKEN STEM WAS THE REASON FOR THE SECOND REVISION. THE ONLY IMPLANT THAT WAS NOT EXPLANTED WAS THE 54 MM PINNACLE REVISION CUP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11813323 ↗
Other Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented devices
- BIOLOX DELTA 1365-32-310Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented551 reports
- PINNACLE ALTRX 1221-36-052Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented481 reports
- BIOLOX DELTA 1365-32-320Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 death314 reports
- BIOLOX DELTA 1365-36-720Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 death189 reports
- DJO SURGICAL 400-03-362Encore Medical, L.P. · Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented187 reports
- Anthology 71365705Smith & Nephew, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented176 reports
- BIOLOX DELTA 1365-40-710Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented170 reports
- PINNACLE GRIPTION 1217-32-054Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented169 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- 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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