MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN LINER NEUT 32IDX52OD; ACETABULAR LINER

Model Number	1218-32-052
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Fall (1848); Pain (1994); Loss of Range of Motion (2032); Osteolysis (2377)
Date of Event	02/11/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision completed due to patient complaints of pain.Patient was asymptomatic following hip surgery until patient suffered a fall.Ambulation quality and distance decreased.Patient complained of pain during activity and at rest.Radiology revealed large osteolyses in trochanter major and minor and poly wear.In conjunction with the radiological findings indication for inlay replacement surgery was given.Doi: (b)(6) 2007; dor: (b)(6) 2022; left hip.
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.
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 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.H10 additional narrative: added: d9 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: examination of the returned device cannot confirm the reported allegation, nothing indicative of a device nonconformance was found.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 (mrae) was not performed.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary = examination of the returned device cannot confirm the reported allegation, nothing indicative of a device nonconformance was found.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 = quantity manufactured: (b)(4).Date of manufacture: 2006-12.Any anomalies or deviations identified in dhr: none found.Expiry date: 2011-11.

• Brand Name: PINN LINER NEUT 32IDX52OD
• Common Device Name: ACETABULAR LINER
• 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: 13619911
• Report Number: 1818910-2022-03743
• Device Sequence Number: 4368810
• Product Code: LPH
• UDI-Device Identifier: 10603295011545
• UDI-Public: 10603295011545
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Device Explanted Year: 2022
• 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): 02/28/2022

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: 1218-32-052
• Device Catalogue Number: 121832052
• Device Lot Number: A69A31000
• 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: 02/15/2022
• Supplement Date Received by Manufacturer: 02/28/2022; 04/01/2022; 04/27/2022; 05/05/2022; 05/19/2022
• Initial Report FDA Received Date: 02/28/2022
• Supplement Report FDA Received Date: 03/17/2022; 04/01/2022; 04/28/2022; 05/12/2022; 05/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/17/2007
• 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; PINNACLE 100 ACET CUP 52MM; UNK HIP ACETABULAR HOLE ELIMINATOR; UNKNOWN HIP FEMORAL HEAD; UNKNOWN HIP FEMORAL HEAD; UNKNOWN HIP FEMORAL STEM; UNKNOWN HIP FEMORAL STEM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 86 YR
• Patient Sex: Female