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

Model Number	N/A
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	08/14/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated report: 0001825034-2021-01278, 0001825034-2021-01280, 0001825034-2021-01281, 0001825034-2021-01282, 0001825034-2021-01283, 0001825034-2021-01284.Medical product: oss avl tibial lock ring, item# 161073, lot# 466660.Oss avl mod tib plate oss tape, item# 161065, lot# 690080.Oss avl tib bearing 12mm, item# 161068, lot# 809890.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 or Problem 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.
Additional 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 or Problem 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 YOKE 12MM
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11739289
• Report Number: 0001825034-2021-01279
• Device Sequence Number: 14394191
• Product Code: KRO
• UDI-Device Identifier: 00880304456143
• UDI-Public: (01)00880304456143(17)281101(10)382130
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K051570
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: consumer,distributor,health p
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/19/2021

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
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 161075
• Device Lot Number: 382130
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/06/2021
• Supplement Date Received by Manufacturer: 05/19/2021
• Initial Report FDA Received Date: 04/28/2021
• Supplement Report FDA Received Date: 05/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention