MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN MAR +4 10D 32IDX48OD; PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS

Model Number	1219-32-148
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Pain (1994); Discomfort (2330)
Date of Event	02/01/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, 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 medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
The patient underwent surgery on (b)(6) 2021.On (b)(6) 2023, she went back to the doctor claiming to have pain and discomfort.She underwent revision surgery, removing the acetabular cup and liner; implanting materials from other orthopedics.Doi: (b)(6) 2021.Dor: (b)(6) 2023.Unknown hip.
Additional Manufacturer Narrative
Product complaint #(b)(4).Investigation summary: the device associated with this complaint was not returned.Photo evidence provided was reviewed and found a portion of the liner's rim was fractured.Additionally, 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.Interlock feature edge of the liner denoted visible ard tabs sheared off from the liner, which is also evidence of the liner having disassociated from the cup.The reported condition was confirmed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot: quantity manufactured: (b)(4).Date of manufacture: 3/10/2020.Any anomalies or deviations identified in dhr: n/a.Expiry date: 2/28/2025.Ifu reference: ifu-0902-00-701.Device history review: a manufacturing record evaluation was performed for the finished device (121932148/j74d84) product and lot numbers,  and no non-conformances were identified.
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).Investigation summary the device associated with this complaint was not returned.Photo evidence provided was reviewed and found a portion of the liner's rim was fractured.Additionally, 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.Interlock feature edge of the liner denoted visible ard tabs sheared off from the liner, which is also evidence of the liner having disassociated from the cup.The reported condition was confirmed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot 1) quantity manufactured: 39 2) date of manufacture: 3/10/2020 3) any anomalies or deviations identified in dhr: n/a 4) expiry date: 2/28/2025 5) ifu reference: (b)(4).Device history review = > a manufacturing record evaluation was performed for the finished device ((b)(4).) product and lot numbers,  and no non-conformances were identified.
Additional Manufacturer Narrative
Product complaint#: (b)(4).Investigation summary: the device associated with this report was returned to depuy synthes for evaluation.Visual analysis of the device found a portion of the liner's rim fractured, fragment was not returned for evaluation.Therefore, the complaint condition can be confirmed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot: 1) quantity manufactured: (b)(4).2) date of manufacture: 3/10/2020.3) any anomalies or deviations identified in dhr: n/a.4) expiry date: 2/28/2025.5) ifu reference: ifu-0902-00-701.

• Brand Name: PINN MAR +4 10D 32IDX48OD
• 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: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 16486036
• Report Number: 1818910-2023-05051
• Device Sequence Number: 6787467
• Product Code: LPH
• UDI-Device Identifier: 10603295014034
• UDI-Public: 10603295014034
• Combination Product (Y/N): N
• Initial Reporter Country: AR
• PMA/510(K) Number: K033273
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2023
• 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): 03/06/2023

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
• Device Expiration Date: 02/28/2025
• Device Model Number: 1219-32-148
• Device Catalogue Number: 121932148
• Device Lot Number: J74D84
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2023
• Supplement Date Received by Manufacturer: 04/17/2023; 07/17/2023; 07/25/2023; 08/15/2023
• Initial Report FDA Received Date: 03/06/2023
• Supplement Report FDA Received Date: 04/17/2023; 07/19/2023; 07/26/2023; 08/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/10/2020
• 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: ARTICUL/EZE BALL 32 +5 BR.; CORAIL2 STD SIZE 11.; PINN CAN BONE SCREW 6.5MMX20MM.; PINN CAN BONE SCREW 6.5MMX30MM.; PINN MAR +4 10D 32IDX48OD.; PINNACLE SECTOR II CUP 48MM.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR
• Patient Sex: Female