MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US BI MENTUM PFRK PFIT CUP 57; BI MENTUM CUP

Model Number	BI-MENTUM PRESSFIT CUP 57
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	09/13/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that the head, stem and poly where exchanged because of infection.Doi: (b)(6) 2021, dor: (b)(6) 2021, right hip.
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.
Event or Problem Description
Question: a.Were there any depuy instrumentation that broke during surgery? if yes, please provide the details.Response: no instruments where broke.No additional information is available.

• Brand Name: BI MENTUM PFRK PFIT CUP 57
• Common Device Name: BI MENTUM CUP
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 12541065
• Report Number: 1818910-2021-50034
• Device Sequence Number: 14450641
• Product Code: LPH
• UDI-Device Identifier: 03662200015023
• UDI-Public: 03662200015023
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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,Followup
• Report Date (Section B): 09/13/2021
• Report Date (Section F): 09/28/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: BI-MENTUM PRESSFIT CUP 57
• Device Catalogue Number: DS45320157
• Device Lot Number: 1902200A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/13/2021
• Date Report to Manufacturer: 09/28/2021
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 10/01/2021
• Initial Report FDA Received Date: 09/28/2021
• Supplement Report FDA Received Date: 10/05/2021
• 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: ACTIS COLLARED HIGH SIZE 7; BI MENTUM PFRK PFIT CUP 57; DELTA CER HEAD 12/14 28MM +1.5; ACTIS COLLARED HIGH SIZE 7; BI MENTUM PFRK PFIT CUP 57; DELTA CER HEAD 12/14 28MM +1.5
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 64 YR
• Date Report Sent to FDA: 09/28/2021