MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ORTHOPEDIC SALVAGE SYSTEM REINFORCED YOKE; PROSTHESIS, KNEE

Model Number N/A

Device Problems Fracture (1260); Naturally Worn (2988)

Patient Problems Abdominal Pain (1685); Failure of Implant (1924); Pain (1994); Hyperextension (4523)

Event Date 06/28/2022

Event Type  Injury  

Event Description

It was reported that the patient underwent a right knee arthroplasty revision to address implant breakage post-operatively.Attempts have been made, however, no additional information is available.

Manufacturer Narrative

(b)(4).Concomitant devices: unknown orthopedic salvage system tibial bearing catalog #: ni lot #: ni, unknown orthopedic salvage system axle catalog #: ni lot #: ni, unknown orthopedic salvage system tibial bushing catalog #: ni lot #: ni, unknown orthopedic salvage system poly lock pin catalog #: ni lot #: ni, unknown orthopedic salvage system femoral bushings catalog #: ni lot #: ni, unknown orthopedic salvage system femoral component catalog #: ni lot #: ni, unknown orthopedic salvage system non-modular tibia catalog #: ni lot #: ni.The complainant has indicated that the product is in process of being 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 patient; please see all reports associated with this event: 0001825034-2022-01658.

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.D10 - concomitant devices - orthopedic salvage system arcom ls tibial bearing 12mm.Catalog #: 161094 lot #: 486590, unknown orthopedic salvage system axle catalog #: ni lot #: 912140, unknown orthopedic salvage system tibial bushing catalog #: ni lot #: 330320, unknown orthopedic salvage system poly lock pin catalog #: ni lot #: 807210, unknown.Orthopedic salvage system femoral bushings catalog #: ni lot #: 606420, unknown.Orthopedic salvage system femoral component 7cm catalog #: ni lot #: 027770, unknown.Orthopedic salvage system non-modular tibia 63mm catalog #: ni lot #: 377970, unknown.Orthopedic salvage system tapered diaphyseal segment catalog #: ni lot #: 495630, unknown orthopedic salvage system bowed stem 11mm x 150mm catalog #: ni lot #: 993980.

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 returned yoke found one of the fins have fractured off.The yoke was submitted for further analysis.Analysis determined the yoke fractured due to fatigue.Eds semi-quantitative elemental analysis of the yoke fracture surface showed that it was consistent with the specifications.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.X-rays were provided however due to poor quality they were not sent for further review.Other medical records were not provided.This complaint was confirmed.A definitive root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Manufacturer Narrative

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

Event Description

It was reported initial right total knee arthroplasty.Subsequently the patient was revised one year, four months later due to pain, hyperextension, and radiographic changes of the rotating platform/yoke.During the revision noted wear to poly, fracture to yoke and impending failure of hinge components.The hinge components were exchanged without complications.The tibia and femur components remained implanted.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Investigation completed on 28 march 2023: (complaint re-opened for medical record received).Medical records were provided and reviewed by a health care professional.Review of the available records identified that the patient experienced pain, hyperextension with stable gait and no instability.X-ray found stable femur and tibial components with interval change of a portion of the rotating platform/yoke.Revision was performed and during the procedure, the poly was found to be worn with fractured yoke.Both femur and tibial were intact.No complication was noted.Complaint was confirmed.No change in root cause, remains as a definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental 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: ORTHOPEDIC SALVAGE SYSTEM REINFORCED YOKE
• 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: 15064299
• MDR Text Key: 296213060
• Report Number: 0001825034-2022-01657
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: 00880304240094
• UDI-Public: (01)00880304240094(17)300926(10)362150
• 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,Followup,Followup,Followup
• Report Date: 03/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2022
• 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: 150493
• Device Lot Number: 362150
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/26/2020
• 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): Hospitalization; Required Intervention
• Patient Sex: Prefer Not To Disclose
• Patient Weight: 66 KG