MAUDE Adverse Event Report: ZIMMER BIOMET, INC. OSS TIBIAL POLY BEARING 22MM; PROSTHESIS, KNEE

Model Number N/A

Device Problems Material Erosion (1214); Unstable (1667); Noise, Audible (3273)

Patient Problems Failure of Implant (1924); Pain (1994); Scar Tissue (2060); Swelling/ Edema (4577)

Event Date 11/22/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical product(s): 150493 - oss reinforced yoke - 481500; 150478 - oss poly lock pin - 8992260; 161035 - oss rs axle - 510260; 150476 - oss poly tibial bushing - 855720; 161034 - oss rs poly fem bushings set/2 - 066260.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2023-00593.

Event Description

It was reported that the patient had a left knee revision approximately 5 months post implantation due to implant fracture, pain, instability, noise, and swelling.During the revision, scar tissue and implant wear was noted.The tibial bearing, bushing, rs axle, femoral bushings set, and locking pin were exchanged without complications.Attempts have been made and no further information has been provided.

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 device history record was reviewed and no discrepancies relevant to the reported event were found.Medical records/radiographs were provided and reviewed by a health care professional.Review of the available records shows that the patient was doing well after the surgery and no complication was noted during prior surgery.After 4 month post-ops, the patient experienced pain, instability, noise, swelling and hyperextension.X-ray found tibial axle flange fracture with diminished bone quality.Revision surgery was performed.During surgery, scar tissue was excised and noted asymmetric wear of the underside of the polyethylene.Confirmed broken flange.Femur was intact.Yoke, locking pin, as axle, tibial bushing and tibial bearing was exchanged.Rom was stable and no complication resulted from surgery.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.

Event Description

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

• Brand Name: OSS TIBIAL POLY BEARING 22MM
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 16713521
• MDR Text Key: 313033739
• Report Number: 0001825034-2023-00730
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 00880304006508
• UDI-Public: (01)00880304006508(17)270309(10)592770
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K002757
• 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: 07/06/2023

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
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 150415
• Device Lot Number: 592770
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/23/2023
• Initial Date FDA Received: 04/11/2023
• Supplement Dates Manufacturer Received: 07/06/2023
• Supplement Dates FDA Received: 07/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/09/2022
• 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
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Male
• Patient Weight: 115 KG