MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US BI MENTUM PFRK CEM CUP 43; BI MENTUM CUP

Model Number	BI-MENTUM CEMENTED CUP 43
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	06/28/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).
Event or Problem Description
Clinical adverse event received for dislocation: competitor head and liner.The bi mentum liner and cup are being reported for the dislocation.Event is considered serious.Event is possibly related to both device and procedure.Date of implant: (b)(6) 2021, date of event: (b)(6) 2021, (left hip).Treatment: closed reduction / manipulation.
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.Corrected: (impact code).
Event or Problem Description
Clinical notification update received which indicates that the hip has now been revised to address the dislocation adverse event.The hip revision occurred on (b)(6) 2021, and the revision log entry reported that the bimentum construct liner assembly (2 components bi mentum pfrk cem cup 43 and bi mentum pfrk pe liner 22 43), and the competitor femoral head and stem proximal body components, were revised.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.Examination of provided x-ray images does identify a dislocation event.The acetabular cup is positioned more vertically than is recommended by depuy.Improper cup positioning can be a factor in dislocation events.Nothing indicative of a product problem is identified.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed, and the investigation will be re-opened as necessary.Device history lot : the product investigation found no evidence suspecting an error in the material, manufacturing, inspection or sterile processing that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

• Brand Name: BI MENTUM PFRK CEM CUP 43
• Common Device Name: BI MENTUM CUP
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 12267052
• Report Number: 1818910-2021-50022
• Device Sequence Number: 17454142
• Product Code: LZO
• UDI-Device Identifier: 03662200015382
• UDI-Public: 03662200015382
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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,Followup
• Report Date (Section B): 07/08/2021
• Report Date (Section F): 08/03/2021

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 Model Number: BI-MENTUM CEMENTED CUP 43
• Device Catalogue Number: DS4901143
• Device Lot Number: 1907185A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/08/2021
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 09/20/2021; 01/21/2022
• Initial Report FDA Received Date: 08/03/2021
• Supplement Report FDA Received Date: 10/06/2021; 01/27/2022
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 1.7 COCR CABLE WITH TI CRIMP 750-STERILE; 1.7 COCR CABLE WITH TI CRIMP 750-STERILE; BI MENTUM PFRK CEM CUP 43; BI MENTUM PFRK PE LINER 22 43; DEPUY/CMW 2G; LFIT V40 FEMORAL HEAD 22.2MM +3MM; RESTORATION CONE BODY; STIMULAN RAPID CURE 10CC; 1.7 COCR CABLE WITH TI CRIMP 750-STERILE; 1.7 COCR CABLE WITH TI CRIMP 750-STERILE; BI MENTUM PFRK CEM CUP 43; BI MENTUM PFRK PE LINER 22 43; DEPUY/CMW 2G; LFIT V40 FEMORAL HEAD 22.2MM +3MM; RESTORATION CONE BODY; STIMULAN RAPID CURE 10CC
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR
• Patient Sex: Female
• Patient Weight: 61 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White
• Date Report Sent to FDA: 08/03/2021