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

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Muscle/Tendon Damage (4532)

Event Date 10/27/2021

Event Type  Injury  

Event Description

It was reported a patient underwent an initial knee arthroplasty.Approximately 2 months post implantation, the doctor repaired a torn tendon and exchanged the poly, tibial and femoral bushings, axle, yoke and locking pin.It was reported that no further information is available.

Manufacturer Narrative

(b)(4).Concomitant products: 150480 - oss axle - 138980; 150476 - oss poly tibial bushing - 153900; 150477 - oss poly femoral bushings - 242510; 150478 - oss poly lock pin - 106170; 150411 - oss tibial poly bearing 14 mm - 706300.The customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product is unavailable due to hospital policy.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2021-03084, 0001825034-2021-03085, 0001825034-2021-03086, 0001825034-2021-03087, 0001825034-2021-03088.

Event Description

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

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.The dhr was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report 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
• 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 Key: 12780668
• MDR Text Key: 280534957
• Report Number: 0001825034-2021-03083
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: 00880304240094
• UDI-Public: (01)00880304240094(17)310713(10)594230
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K052685
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 150493
• Device Lot Number: 594230
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/13/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE.
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Female