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

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Pain (1994); Loss of Range of Motion (2032)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Implant date occurred between (b)(6) 2020.Concomitant medical products: unknown articular surface, catalog#: ni, lot#: ni; unknown tibial tray, catalog#: ni, lot#: ni.Report source: foreign: germany.Multiple mdr reports have been filed for this event.Please see associated reports: 0001822565-2022-02612; 0001822565-2022-02613.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that a patient underwent an initial knee arthroplasty.Subsequently, for two years post-implantation, the patient has experienced pain and limited mobility of the implanted joint.The patient has consulted with surgeons but has not undergone treatment or reached resolution of the issue.It was reported that no further information is available regarding this event and the final patient outcome remains unknown.

Event Description

No further event information at time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.H6: proposed component (annex g) code is mechanical (g04) - femur.Visual and dimensional evaluations of the product could not be performed as no product was returned nor were pictures provided.Device history record review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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.

• Brand Name: UNKNOWN FEMORAL COMPONENT
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 15405723
• MDR Text Key: 299752199
• Report Number: 0001822565-2022-02611
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/19/2022
• 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
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE.
• Patient Outcome(s): Other
• Patient Sex: Prefer Not To Disclose