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	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Fall (1848); Joint Dislocation (2374)
Date of Event	10/18/2023
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
Patient fell and dislocated.The original cup surgery was on (b)(6) 2021.The original system used was a competitor stem, so only the cup that was put in on (b)(6) 2021 was a depuy product.On (b)(6) 2021 the patient fell again, and the depuy liner was revised to a constrained liner.Cup placement is good, so the surgeon is implanting another constrained liner.Doi: (b)(6) 2021, dor: (b)(6) 2023, affected side: left.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: pt fell last night and dislocated.Pt is a chronic faller due to the fact that she refuses to get spine surgery.The original cup surgery was on (b)(6) 2021.The original system used was a styker stem, so only the cup that was put in on (b)(6) 2021 was a depuy product.On (b)(6) 2021 the patient fell again, and the depuy liner was revised to a constrained liner.Cup placement is good, so the surgeon is implanting another constrained liner and requesting that the patient again gets her needed spinal surgery to prevent more falls.The product was not returned to depuy synthes, however photos were provided for review.See attachment [(b)(4) x-ray films ad (b)(6) 2023].The x-ray investigation revealed that pin lnr cons neut +4 36idx60od has dislocated the head from the liner, based on the information provided it is suspected that the patient's fall might have contributed to the reported dislocation, a root cause cannot be determined.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection not completed.The overall complaint was confirmed as the observed condition of the pin lnr cons neut +4 36idx60od would contribute to the complained device issue.Based on the investigation findings, and it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.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: 2/23/21; 3) any anomalies or deviations identified in dhr: none; 4) expiry date: 01/31/2025; 5) ifu reference: ifu-0902-00-805 rev.6.Device history review: 1) quantity manufactured: (b)(4); 2) date of manufacture: 2/23/21; 3) any anomalies or deviations identified in dhr: none; 4) expiry date: 01/31/2025; 5) ifu reference: ifu-0902-00-805 rev.6.

• 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
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 18046693
• Report Number: 1818910-2023-22136
• Device Sequence Number: 8254614
• Product Code: KWZ
• UDI-Device Identifier: 10603295012146
• UDI-Public: 10603295012146
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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: 2023
• 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): 11/01/2023

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 Expiration Date: 01/31/2026
• Device Catalogue Number: 121836660
• Device Lot Number: JA9283
• 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: 10/18/2023
• Supplement Date Received by Manufacturer: 11/21/2023
• Initial Report FDA Received Date: 11/01/2023
• Supplement Report FDA Received Date: 11/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/23/2021
• 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: UNKNOWN HIP FEMORAL HEAD.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR
• Patient Sex: Female