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: 0001825034-2021-01218 0001825034-2021-01219 0001825034-2021-01220 0001825034-2021-01221 0001825034-2021-01222 0001825034-2021-01223 0001825034-2021-01224 0001825034-2021-01225 0001825034-2021-01226 concomitant medical products: 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 reinforced yoke, item# 150493 lot# 658130 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.

Manufacturer Narrative

This follow-up is being submitted to relay additional information.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.

Event Description

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

• 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: 11716182
• MDR Text Key: 258675472
• Report Number: 0001825034-2021-01217
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: 00880304240094
• UDI-Public: (01)00880304240094(17)280909(10)211420
• 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

• Date FDA Received: 04/23/2021
• 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: 211420
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention