MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US BI MENTUM PFRK PE LINER 22 41; HIP IMPLANT : BI MENTUM LINER

Model Number	BI-MENTUM PE Liner 22,2 / 41
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Joint Dislocation (2374); Physical Asymmetry (4573)
Date of Event	06/08/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).
Event or Problem Description
It was reported that the patient dislocated during a physical therapy session.Was brought to or for open reduction.Head and liner were exchanged to lengthen the hip slightly due to leg length discrepancy noted by the patient but was intentionally left short after multiple surgeries due to contraction of soft tissues.Doi: (b)(6) 2021 dor: (b)(6) 2021 affected side: left hip.

• Brand Name: BI MENTUM PFRK PE LINER 22 41
• Common Device Name: HIP IMPLANT : BI MENTUM LINER
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 12083462
• Report Number: 1818910-2021-50018
• Device Sequence Number: 3235726
• Product Code: LZO
• UDI-Device Identifier: 03662200015498
• UDI-Public: 03662200015498
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/08/2021
• Report Date (Section F): 06/29/2021

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: BI-MENTUM PE Liner 22,2 / 41
• Device Catalogue Number: DS10014122
• Device Lot Number: 2002646A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/08/2021
• Device Age: 1 MO
• Event Location: Hospital
• Date Report to Manufacturer: 06/29/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ARTICUL/EZE BALL 22.225+4 NK; BI MENTUM PFRK PE LINER 22 41
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR
• Date Report Sent to FDA: 06/29/2021