MAUDE Adverse Event Report: ZIMMER BIOMET, INC. OSS REINFORCED YOKE; PROSTHESIS, KNEE

Model Number N/A

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Damage to Ligament(s) (1952); Pain (1994); Impaired Healing (2378)

Event Date 03/12/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated report: 0001825034-2021-01217, 0001825034-2021-01218, 0001825034-2021-01219, 0001825034-2021-01220, 0001825034-2021-01221, 0001825034-2021-01222, 0001825034-2021-01223, 0001825034-2021-01224, 0001825034-2021-01226.Medical product: oss reinforced yoke item# 150493 lot# 211420; oss tibial poly bearing 20mm item# 150414 lot# 237060; oss poly lock pin item# 150478 lot# 348850; oss non-mod tib plate short 67 item# 150417 lot# 203610; oss 7cm segmental femoral rt item# 150354 lot# 756200; oss poly tibial bushing item# 150476 lot# 460720; oss poly femoral bushings item# 150477 lot# 370100; oss axle item# 150480 lot# 543370; oss tibial poly bearing 22mm item# 150415 lot# 382120; oss 3cm ellip diaphyseal seg item# 150461 lot# 150610; oss cemented im stem 15mmx90mm item# 150363 lot# 810360.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that a patient was revised approximately two months¿ post implantation due to wound healing problems that disengaged his hinged femur from his right tibial component.This was a result of having had a distal femoral replacement with absence of collateral ligaments causing the femur to disengage from the tibia when the knee became flexed.Attempts to obtain additional information have been made; however, no more information is available.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

This follow-up is being submitted to relay additional information.Updated: b4, b5, g3, g6, h1, h2, h3, h6, and h10.No product was returned or pictures provided; therefore, visual and dimensional evaluations could not be performed.Medical records were not provided.Device history record (dhr) was reviewed for deviations and/ or anomalies with no related deviations / anomalies identified.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: OSS REINFORCED YOKE
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11716334
• MDR Text Key: 247231152
• Report Number: 0001825034-2021-01225
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: 00880304240084
• UDI-Public: (01)00880304240084(17)281108(10)658130
• Combination Product (y/n): N
• PMA/PMN Number: K052685
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,distributor,health p
• Type of Report: Initial,Followup
• Report Date: 06/03/2021

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 Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 150493
• Device Lot Number: 658130
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/06/2021
• Initial Date FDA Received: 04/23/2021
• Supplement Dates Manufacturer Received: 06/02/2021
• Supplement Dates FDA Received: 06/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10
• Patient Outcome(s): Hospitalization; Required Intervention