MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US BI MENTUM PFRK PE LINER 28 53; BI MENTUM LINER

Model Number	BI-MENTUM PE LINER 28 / 53
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Hematoma (1884); Pain (1994); Joint Dislocation (2374); Fluid Discharge (2686); Joint Laxity (4526); Unspecified Tissue Injury (4559)
Date of Event	04/30/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).
Event or Problem Description
On (b)(6) 2020, the patient had a revision of left total hip arthroplasty to address wound breakdown with hematoma and drainage, recurrent instability with dislocation, and coagulopathy.The indications for surgery included that the patient had a revision 6 weeks prior (captured in pc-(b)(4)) to address a failed constrained liner and medical records indicated the patient was having pain.The patient dislocated after that surgery and needed a reduction.During this current procedure the acetabular and femoral components were revised.The surgeon reported finding a complete failure of the posterior soft tissue, and really no longer any soft tissues present to repair.There was a small amount of hematoma.He was coagulopathic during the case.

• Brand Name: BI MENTUM PFRK PE LINER 28 53
• Common Device Name: BI MENTUM LINER
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 11871929
• Report Number: 1818910-2021-50014
• Device Sequence Number: 13668235
• Product Code: LZO
• UDI-Device Identifier: 03662200015672
• UDI-Public: 03662200015672
• 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
• Report Date (Section B): 05/05/2021
• Report Date (Section F): 05/24/2021

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 28 / 53
• Device Catalogue Number: DS10015328
• Device Lot Number: 1907058A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/05/2021
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 06/29/2022
• Initial Report FDA Received Date: 05/24/2021
• Supplement Report FDA Received Date: 07/05/2022
• Date Device Manufactured: 10/25/2019
• 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: APEX HOLE ELIM POSITIVE STOP.; BI MENTUM PFRK PE LINER 28 53.; PINN CAN BONE SCREW 6.5MMX20MM.; PINN CAN BONE SCREW 6.5MMX25MM.; PINNACLE DM LINER 64_53.; PINNACLE SECTOR II CUP 64MM.; S-ROM*HEAD FEMORAL COCR 28+12.; S-ROM*SLEEVE PRX ZTT, 20F-LRG.; SROM STM STD 36+12L 15X20.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 88 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White
• Date Report Sent to FDA: 05/24/2021