MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TI OSS 7CM RT SGMT DSTL FMR; PROSTHESIS, KNEE

Model Number N/A

Device Problem Unstable (1667)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Manufacturer Narrative

On (b)(4) customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Additional associated products & mdrs (b)(4) ti oss reinforced yoke lot# unk mdr: 0001825034-2023-00310 (b)(4) ti oss lkg axle cap and scrw lot# unk mdr: 0001825034-2023-00311 (b)(4) ti oss poly tib bushing set lot# unk mdr: 0001825034-2023-00312 associated product (b)(4) ti oss 67mm mod tib bsplt lot# unk.

Event Description

It was reported the patient's knee is unstable due to varus/valgus stress and it appears the axle, yoke, and/or femoral bushings have failed.It is noted the patient is planned to be revised.Attempts to gather additional information are underway but no additional information is available at this time.

Manufacturer Narrative

This follow-up report is being submitted to correct previously reported information.Upon receiving additional information, it was determined that the part referenced should not have been reported as it was not believed to have contributed to or caused the event.The initial report should be voided.

Event Description

Upon receiving additional information it was determined that the part referenced should not have been reported.The initial report should be voided.

• Brand Name: TI OSS 7CM RT SGMT DSTL FMR
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 16387091
• MDR Text Key: 309671839
• Report Number: 0001825034-2023-00340
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: CP0002525
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/31/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male