MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US BI MENTUM PFRK PE LINER 28 47; BI MENTUM PE LINER

Model Number BI-MENTUM PE Liner 28 / 47

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Fall (1848); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 06/15/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that patient had a fall and actually disassociated the head from the liner.Patient was brought back for revision surgery and revised to a new cup and dual mobility.Doi: (b)(6) 2021, dor: (b)(6) 2021, right hip.

• Brand Name: BI MENTUM PFRK PE LINER 28 47
• Type of Device: BI MENTUM PE LINER
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 12121971
• MDR Text Key: 260055433
• Report Number: 1818910-2021-50021
• Device Sequence Number: 1
• Product Code: KWY
• UDI-Device Identifier: 03662200015641
• UDI-Public: 03662200015641
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/15/2021

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
• Device Operator: Health Professional
• Device Model Number: BI-MENTUM PE Liner 28 / 47
• Device Catalogue Number: DS10014728
• Device Lot Number: 1909312A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 06/15/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: BI MENTUM PFRK PE LINER 28 47; DLT TS CER HD 12/14 28MM +8.5; PINNACLE DM LINER 54_47
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR
• Patient Weight: 81