MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN PERSONA PARTIAL KNEE FEMORAL COMPONENT; PROSTHESIS, KNEE

Model Number N/A

Device Problems Unstable (1667); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Arthritis (1723); Failure of Implant (1924)

Event Date 06/07/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant devices - unknown persona partial knee tibial component catalog #: ni lot #: ni, unknown persona partial knee articular surface catalog #: ni lot #: ni.Report source - foreign: (b)(6).The complainant has not yet indicated whether the product will 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.Investigation incomplete.

Event Description

It was reported that the patient underwent a knee arthroplasty revision to address aseptic femoral component loosening, instability and progression of arthritis approximately 2.5 years post-operatively.Attempts have been made, however, no additional information is available at this time.

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.The product could not be evaluated and the reported event was not confirmed.The device history records could not be reviewed as the lot number associated with the reported event is unknown.A definitive root cause could not be determined with the information provided.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.

• Brand Name: UNKNOWN PERSONA PARTIAL KNEE FEMORAL COMPONENT
• 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: 12598912
• MDR Text Key: 275843407
• Report Number: 0001825034-2021-02831
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 11/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2021
• 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
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/11/2021
• 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
• Treatment: SEE H10 NARRATIVE
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 65 YR
• Patient Sex: Prefer Not To Disclose