MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN ORTHOPEDIC SALVAGE SYSTEM TIBIAL BEARING; PROSTHESIS, KNEE

Model Number N/A

Device Problem Naturally Worn (2988)

Patient Problem Failure of Implant (1924)

Event Date 10/01/2021

Event Type  Injury  

Event Description

It was reported that one (1) patient underwent a knee arthroplasty revision of the tibial bearing to address post-operative implant wear.Attempts have been made, however, no additional information is available.

Manufacturer Narrative

(b)(4).Groundland, j., brown, j.M., monument, m.Bernthal, n.Jones.K.B., randall, r.L.(1 oct 2021) what are the long-term surgical outcomes of compressive endoprosthetic osseointegration of the femur with a minimum 10-year follow-up period? clinical orthopaedics and related research, 480(3)539-548.Https://doi.Org/10.1097/corr.0000000000001979.Concomitant devices - unknown orthopedic salvage system distal femur catalog #: ni lot #: ni, unknown orthopedic salvage system tibia catalog #: ni lot #: ni, unknown orthopedic salvage system spindle catalog #: ni lot #: ni, unknown orthopedic salvage system diaphyseal connector catalog #: ni lot #: ni, unknown orthopedic salvage system taper adapter catalog #: ni lot #: ni.Initial reporter- correspondence author.It is currently 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.

Manufacturer Narrative

The reported event was unable to be confirmed due to lack of information received.No product, pictures, or medical records were provided.A review of the device history records could not be performed as part and lot information was not provided.A root cause could not 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 additional information.

• Brand Name: UNKNOWN ORTHOPEDIC SALVAGE SYSTEM 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: 15539940
• MDR Text Key: 301139128
• Report Number: 0001825034-2022-02245
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: Prefer Not To Disclose