MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 PINNACLE DM LINER 54_47; TOTAL HIP JOINT REPLACEMENT PROSTHESIS

Catalog Number	121854047
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	01/04/2024
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
Patient was revised due to dislocation.Bi-mentum liner popped off of 28 head when it dislocated.Doi: (b)(6), 2021.Dor: (b)(6), 2024.Affected side: right hip.
Event or Problem Description
Additional information received: a.Was there a surgical delay? if yes, what is the duration of the delay? no.B.Could you please confirm the finding of the complaint ¿liner popped from 28 head¿? it seems unlikely that a liner pops from a head as the head is impacted by the liner? i believe it dislocated and the liner came off of the head when they tried to close and reduce it.
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: no device associated with this report was received for examination.A non-conformance search for the provided lot number/product code combination was conducted and no reports related to the reported event were found.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: a non-conformance search for the provided lot number/product code combination was conducted and no reports related to the reported event were found.

• Brand Name: PINNACLE DM LINER 54_47
• Common Device Name: TOTAL HIP JOINT REPLACEMENT PROSTHESIS
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): CORK MFG & MATERIAL WAREHOUSE; loughbeg ringaskiddy; cork ; EI
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 18482834
• Report Number: 1818910-2024-00729
• Device Sequence Number: 9016736
• Product Code: LPH
• UDI-Device Identifier: 10603295520283
• UDI-Public: 10603295520283
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K200854
• 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,Followup
• Report Date (Section B): 01/10/2024

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 121854047
• Device Lot Number: 9781808
• 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: 12/26/2023
• Supplement Date Received by Manufacturer: 01/15/2024; 01/25/2024
• Initial Report FDA Received Date: 01/10/2024
• Supplement Report FDA Received Date: 01/17/2024; 01/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/06/2021
• 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: BI MENTUM PFRK PE LINER 28 47; DELTA CER HEAD 12/14 28MM +1.5
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 58 YR
• Patient Sex: Female
• Patient Weight: 64 KG