MAUDE Adverse Event Report: DEPUY IRELAND - 3015516266 PINNACLE DM LINER 56_49; TOTAL HIP JOINT REPLACEMENT PROSTHESIS

Model Number 1218-56-049

Device Problems Off-Label Use (1494); Device Dislodged or Dislocated (2923)

Patient Problem Joint Dislocation (2374)

Event Date 03/21/2023

Event Type  Injury  

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 Description

Dislocated pdm liner replaced with constrained liner.Doi: (b)(6) 2023.Dor: (b)(6) 2023.Unknown side.

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.Corrected:.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : according to the information received, ¿dislocated pdm liner replaced with constrained liner¿ the product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis of the device found no damage or defects that could have contributed to the reported condition.Based on the observations, it is not possible to confirm a dislocation between the bi mentum altrx lnr 49 28 and the pinnacle dm liner 56_49.Additionally, the device was used for an indication not in the approved labeling, a dual mobility liner is not intended to be used with a bi mentum liner since these implants are from different systems and both are acetabular liners the overall complaint was confirmed for pinnacle dm liner 56_49.Based on the investigation findings, the potential cause can be traced to user due to off label use 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 reported 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 : a manufacturing record evaluation was performed for the finished device [121856049/9828188] number, and no non-conformances / manufacturing irregularities related to the malfunction were identified.

• Brand Name: PINNACLE DM LINER 56_49
• Type of Device: TOTAL HIP JOINT REPLACEMENT PROSTHESIS
• Manufacturer (Section D): DEPUY IRELAND - 3015516266; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 16760911
• MDR Text Key: 313490362
• Report Number: 1818910-2023-08126
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 10603295520290
• UDI-Public: 10603295520290
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K200854
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/18/2023

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
• Device Operator: Health Professional
• Device Model Number: 1218-56-049
• Device Catalogue Number: 121856049
• Device Lot Number: 9828188
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/31/2023
• Initial Date FDA Received: 04/18/2023
• Supplement Dates Manufacturer Received: 05/09/2023; 12/07/2023
• Supplement Dates FDA Received: 05/10/2023; 12/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/23/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: BI MENTUM ALTRX LNR 49 28; DLT TS CER HD 12/14 28MM +5.0; PINNACLE DM LINER 56_49; UNKNOWN HIP ACETABULAR CUP
• Patient Outcome(s): Required Intervention
• Patient Sex: Male