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U.S. Department of Health and Human Services

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

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ZIMMER BIOMET, INC. OSS REINFORCED YOKE PROSTHESIS, KNEE Back to Search Results
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.
 
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Brand NameOSS REINFORCED YOKE
Type of DevicePROSTHESIS, KNEE
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
Manufacturer (Section G)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key11716334
MDR Text Key247231152
Report Number0001825034-2021-01225
Device Sequence Number1
Product Code KRO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K052685
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,distributor,health p
Reporter Occupation
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 Received04/23/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number150493
Device Lot Number658130
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received06/02/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/08/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 04/23/2021 Patient Sequence Number: 1
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