MAUDE Adverse Event Report: ZIMMER BIOMET, INC. OSS RS 12MM LS TIBIAL BEARING; PROSTHESIS, KNEE

Model Number N/A

Device Problems Fracture (1260); Unstable (1667)

Patient Problems Failure of Implant (1924); Pain (1994); Ambulation Difficulties (2544); Joint Laxity (4526)

Event Date 07/10/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).D10: 150476 - oss poly tibial bushing - 364410.161034 - oss rs poly fem bushings set/2 - 659600.150478 - oss poly lock pin - 833270.161035 - oss rs axle - 168370.150493 - oss reinforcd yoke - 584150.150427 - oss tib blk aug 10x71/75 univ - 385370.150427 - oss tib blk aug 10x71/75 univ - 126010.150400 - oss porous im stem 21.5 x 150 - 795170.161041 - oss rs non-mod plt long 71 - 942080r.161014 - oss rs 8.5cm ellip seg fmrl-lt - 419750.Customer has indicated that the product will not be returned to zimmer biomet for investigation.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: 0001825034-2023-01780, 0001825034-2023-01781, 0001825034-2023-01782, 0001825034-2023-01783, and 0001825034-2023-01784.

Event Description

It was reported that the patient underwent an initial knee surgery.Subsequently, the patient presented with left knee pain and instability approximately five years postop and underwent a revision surgery.The bearing and bushing kit were revised.Attempts have been made and all available information has been provided.

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.Visual examination of the provided pictures identified explanted axle, yoke, bushings and bearing.The polyethylene bearing is worn unevenly.The bushings and the bearing also show signs of damage and fracture.It is assumed to be caused by the explanation of the devices but unknown.The device history record was reviewed and no discrepancies relevant to the reported event were found.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: polyethylene wear, two radio-opaque objects are noted not connected to the implants, bone quality is osteopenic, no evidence of implant loosening.Lateral polyethylene wear with valgus malalignment as noted.This could result in pain/instability.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

It was further reported that the patient reported clunking, instability, and pain and was revised.During the revision, the poly insert was noted to be broken.No intraoperative complications reported.From provided images, the yoke and tibial bushing were also fractured.Attempts have been made and all available information has been provided.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

• Brand Name: OSS RS 12MM LS TIBIAL BEARING
• 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: 17452225
• MDR Text Key: 320323551
• Report Number: 0001825034-2023-01779
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: 00880304467989
• UDI-Public: (01)00880304467989(17)230222(10)068590
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K021260
• 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,Followup
• Report Date: 05/21/2024

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 Expiration Date: 02/22/2023
• Device Model Number: N/A
• Device Catalogue Number: 161094
• Device Lot Number: 068590
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/12/2023
• Initial Date FDA Received: 08/03/2023
• Supplement Dates Manufacturer Received: 11/16/2023; 05/08/2024
• Supplement Dates FDA Received: 11/17/2023; 05/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/22/2018
• 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...
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Male
• Patient Weight: 99 KG