MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN 100 W/GRIPTION 52MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

Model Number	1217-31-052
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Joint Laxity (4526); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	08/27/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
The surgeon performed a revision total hip arthroplasty on a patient who had been playing soccer and complained of a strange instability that began to occur during soccer.The surgeon exposed and found that the liner had dissociated from the shell.The surgeon noted that the liner showed signs of deformation and the ard tabs had sheared off.The ceramic femoral head had visible stripe wear.The shell was well-fixed and in good condition.The stem was well-fixed and in good condition.If the liner had not disassociated, the stripe wear would not have occurred.The surgeon then removed the damaged head and liner, washed and irrigated the wound thoroughly, and proceeded to implant a new femoral head and new liner which matched the size of the previous liner.The surgery finished successfully according to plan.Doi: unknown dor: (b)(6) 2021.Unknown side.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary no device associated with this report was received for examination.All available product photographs/xrays were reviewed.Based on the photo evidence provided, complaint is confirmed.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed, and the investigation may be re-opened as necessary.Device history lot the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

• Brand Name: PINN 100 W/GRIPTION 52MM
• Common Device Name: PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 12495612
• Report Number: 1818910-2021-20474
• Device Sequence Number: 11739552
• Product Code: KWA
• UDI-Device Identifier: 10603295010203
• UDI-Public: 10603295010203
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K090998
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1217-31-052
• Device Catalogue Number: 121731052
• Device Lot Number: J86M99
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2021
• Supplement Date Received by Manufacturer: 11/22/2021
• Initial Report FDA Received Date: 09/20/2021
• Supplement Report FDA Received Date: 11/22/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/28/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CORAIL AMT SZ11 135 HIGH COL; DELTA CER HEAD 12/14 32MM +1; PINN 100 W/GRIPTION 52MM; PINN MAR +4 10D 32IDX52OD; CORAIL AMT SZ11 135 HIGH COL; DELTA CER HEAD 12/14 32MM +1; PINN 100 W/GRIPTION 52MM; PINN MAR +4 10D 32IDX52OD
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown