MAUDE Adverse Event Report: ZIMMER BIOMET, INC. OSS AVL TIB BEARING 12MM; PROSTHESIS, KNEE

Model Number N/A

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Failure of Implant (1924); Pain (1994)

Event Date 08/14/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated report: 0001825034-2021-01278, 0001825034-2021-01279, 0001825034-2021-01280, 0001825034-2021-01282, 0001825034-2021-01283, 0001825034-2021-01284.Concomitant medical products: oss avl tibial lock ring, item# 161073, lot# 466660.Oss avl yoke 12mm, item# 161075, lot# 382130.Oss avl mod tib plate oss tape, item# 161065, lot# 690080.Oss tib blk aug 10x63/67 univ, item# 150426, lot# 105590.Oss avl poly tib bushing set, item# 161071, lot# 490920.Oss poly femoral bushings, item# 150477, lot# 499870.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 five months post-implantation due to locking nut fractured in two pieces and allowed piston to disengage from the tibial component.Attempts to obtain additional information have been made; however, no more information is available.

Manufacturer Narrative

Upon further investigation, it was determined that this item was reported in error.The locking ring fracture is what caused the yoke to disassociate from the tibial tray.Therefore, the locking ring is the only reportable item.The initial report was submitted in error and should be voided.

Event Description

Upon further investigation, it was determined that this item was reported in error.The locking ring fracture is what caused the yoke to disassociate from the tibial tray.Therefore, the locking ring is the only reportable item.The initial report was submitted in error and should be voided.

• Brand Name: OSS AVL TIB BEARING 12MM
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11739339
• MDR Text Key: 247772745
• Report Number: 0001825034-2021-01281
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: 00880304456136
• UDI-Public: (01)00880304456136(17)230907(10)809890
• Combination Product (y/n): N
• PMA/PMN Number: K051570
• 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: 05/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/07/2023
• Device Model Number: N/A
• Device Catalogue Number: 161068
• Device Lot Number: 809890
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/19/2021
• 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