MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN HIP ACETABULAR CUP; PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS

Model Number	1219-32-052
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Noise, Audible (3273)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Discomfort (2330)
Date of Event	03/15/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (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
Revision completed due to pain and audible sound during ambulation.The patient then complained that the hip was ¿squeaking¿ and sore and sought help.There was evidence of metallosis shortly after skin incision, the acetabular liner had dislocated from the acetabular shell and the ceramic head showed significant wear.The procedure was made considerably more complicated as the head was reportedly ¿stuck¿ in the liner and it was difficult to dislocate the hip.It was necessary to use a saw to make a cut on the liner for the purpose of levering the liner to dislocate the hip and remove the head.Doi: (b)(6) 2021; dor: (b)(6) 2022; right hip.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.However, based on examination of the ceramic head and poly liner it was possible to confirm the disassociation event.The liner denoted considerable signs of wear and a remarkable deformation on the edge.Two ard tabs of the liner was sheared off from the rest of the part as consequence of the liner disassociation from the cup additionally, it occurred a transfer of the titanium cup material onto the surface of the ceramic head.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot : a manufacturing records evaluation (mre) was not performed as no lot number was provided for this device.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : the device associated with this report was received for examination.Based on visual examination of the poly liner it was possible to confirm the disassociation event.It is evident that the edge of the liner was loaded by the femoral head and patient body weight while implanted, causing the deformation in the rim of the device.The liner denoted considerable signs of wear and a remarkable deformation on the edge.Three ard tabs of the liner were sheared off from the part as consequence of the liner disassociation from the cup.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will 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.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4).This medwatch report was initially submitted on 9/22/2022.This report is being resubmitted as this report failed submission as a result of the electronic gateway.Fda ticket (b)(4) for additional details.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: the device associated with this report was not received for analysis.Based in the visual examination of the involved poly liner, a disassociation event was able to be confirmed.It is not unreasonable that noise would be present due to the ceramic head articulating against the metal cup.It is subsequent the liner disassociation and does not signify any product error.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed, and the investigation will be re-opened as necessary.Device history lot : due to damage on the device's edge, product information was not possible to be retrieved.A manufacturing records evaluation (mre) was not performed as no lot number was provided for this device.

• Brand Name: UNKNOWN HIP ACETABULAR CUP
• Common Device Name: PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS
• 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: amy hendrickson ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 5743674841
• MDR Report Key: 13950745
• Report Number: 1818910-2022-05801
• Device Sequence Number: 14650551
• Product Code: LPH
• UDI-Device Identifier: 10603295013907
• UDI-Public: 10603295013907
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• PMA/510(K) Number: K001534
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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,Followup,Followup,Followup
• Report Date (Section B): 09/22/2022

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: 1219-32-052
• Device Catalogue Number: UNK HIP ACETABULAR CUP
• Device Lot Number: 3651532
• 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: 03/15/2022
• Supplement Date Received by Manufacturer: 06/17/2022; 08/26/2022; 09/06/2022; 09/20/2022; 01/17/2023
• Initial Report FDA Received Date: 03/30/2022
• Supplement Report FDA Received Date: 06/20/2022; 08/31/2022; 09/08/2022; 12/01/2022; 01/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/10/2021
• 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: DLT TS CER HD 12/14 32MM +5.; PINN MAR NEUT 32IDX52OD.; PINN MAR NEUT 50ODX32ID.; UNKNOWN HIP ACETABULAR CUP.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown