MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN MAR +4 10D 32IDX52OD; PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS

Model Number	1219-32-152
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Pain (1994); Discomfort (2330); Joint Laxity (4526)
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
Surgeon gave a call directly to complaint handling unit: implantation of hip-tep right side on (b)(6) 2019.Revision of inlay and hip head on (b)(6) 2023 as inlay disassociated from cup.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.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: dhr details for product name: pinn mar +4 10d 32idx52od, product code:121932152,lot:j44z15 1) quantity manufactured:(b)(4) 2) date of manufacture: 2019-07-22 3) any anomalies or deviations identified in dhr: no non-conformance were identified 4) expiry date: 2024-06-30 5) ifu reference: 090200701.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: the device associated with this report was returned to depuy synthes for evaluation.Visual examination of the device was able to confirm the disassociation event of the liner from the cup.A portion of the rim has broken off from the liner.It is evident that the edge of the liner was loaded by the femoral head and patient body weight while implanted.There are machining lines from the manufacturing process yet visible within the liner which would not be as obviously present had the femoral head been more centrally loaded.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot: dhr details for product name: pinn mar +4 10d 32idx52od, product code:121932152, lot:j44z15.1) quantity manufactured: (b)(4); 2) date of manufacture: 2019-07-22; 3) any anomalies or deviations identified in dhr: no non-conformance were identified; 4) expiry date: 2024-06-30; 5) ifu reference: 090200701.Device history review: a manufacturing record evaluation was performed for the finished device 121932152 /j44z15] number, and no non-conformances / manufacturing irregularities were identified.

• Brand Name: PINN MAR +4 10D 32IDX52OD
• 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: 16395752
• Report Number: 1818910-2023-03944
• Device Sequence Number: 6433271
• Product Code: LPH
• UDI-Device Identifier: 10603295014058
• UDI-Public: 10603295014058
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K001534
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• 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
• Report Date (Section B): 02/17/2023

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
• Operator of Device: Health Professional
• Device Model Number: 1219-32-152
• Device Catalogue Number: 121932152
• Device Lot Number: J44Z15
• 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: 02/02/2023
• Supplement Date Received by Manufacturer: 04/05/2023; 05/31/2023
• Initial Report FDA Received Date: 02/17/2023
• Supplement Report FDA Received Date: 04/06/2023; 06/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/22/2019
• 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: HIP BALL BIOLOX 32 +1 12/14; PINN MAR +4 10D 32IDX52OD; PINNACLE 100 ACET CUP 52MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female