MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PIN LNR CONS NEUT +4 36IDX60OD; PINNACLE HIP SYSTEM : HIP CONSTRAINED ACETABULAR LINERS

Catalog Number	121836660
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	06/06/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).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, or its employees that the report constitutes an admission that the product, 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 report, a follow-up report will be filed as appropriate.
Event or Problem Description
It was reported that the possible infected total hip was washed out.The proximal body for the reclaim stem was attempted to be removed.The disassembly tool was inserted into proximal body to disengage it, but the teeth on the collet portion sheared off while trying to separate body from stem.This was attempted with two different disassembly tools, and the teeth sheared off both collet portions of the disassembly tools.The body was not able to be disengaged.The constrained liner and head were exchanged during the washout portion of this procedure.Doi: (b)(6) 2021.Dor: (b)(6) 2024.Affected side: left hip.
Event or Problem Description
Additional information was received and stated that there was a 20 to 30-minute surgical delay in attempting to separate the body which was unsuccessfully done.No reports of patient harm.
Additional Manufacturer Narrative
Product complaint: (b)(4).Investigation summary: no device associated with this report was received for examination.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 records evaluation (mre) was not perform.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.If additional information is made available, the investigation will be updated as applicable.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: PIN LNR CONS NEUT +4 36IDX60OD
• Common Device Name: PINNACLE HIP SYSTEM : HIP CONSTRAINED ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 19615069
• Report Number: 1818910-2024-13946
• Device Sequence Number: 12311337
• Product Code: KWZ
• UDI-Device Identifier: 10603295012146
• UDI-Public: 10603295012146
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K043058
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2024

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2026
• Device Catalogue Number: 121836660
• Device Lot Number: JD0911
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/06/2024
• Supplement Date Received by Manufacturer: 06/28/2024
• Initial Report FDA Received Date: 06/26/2024
• Supplement Report FDA Received Date: 07/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/09/2021
• 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 36MM +12.; UNK HIP FEMORAL STEM RECLAIM DISTAL STEM.; UNK HIP FEMORAL STEM RECLAIM PROXIMAL BODY.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male