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

Model Number N/A

Device Problem Fracture (1260)

Patient Problems Ossification (1428); Metal Related Pathology (4530)

Event Date 03/22/2001

Event Type  Injury  

Manufacturer Narrative

(b)(4).D6a - implant date - unknown date in 1985.D10 - concomitant devices - bl tibial component with stem large, catalog #: rd108565, lot #: ni.Unknown tibial bearing set, catalog #: ni, lot #: ni.Unknown axel, catalog #: ni, lot #: ni.Bl tibial bushing set left, catalog #: cp111173, lot #: ni, bl tibial.The complainant has 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.H3 other text : insufficient information.

Event Description

It was reported that the patient underwent a left knee arthroplasty revision to address post-operative fracture of the femoral component approximately sixteen (16) years post-operatively.Revision operative notes noted that the femoral neck had fractured off where it abutted against the tibial plateau and no plastic was there to act as a bumper guard.The prosthesis was easily removed.There was a bony edge approximately one centimeter that was removed proximally, allowing the ring to be unscrewed and displaced.A large amount of black material was also noted, which was removed prior to placement of new components.No intraoperative complications were reported.Attempts have been made; however, no additional information is available.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.H6 - component code - proposed code is mechanical (g4) femur.Medical records provided confirmed reported event.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.

Event Description

No further event information available at the time of this report.

• Brand Name: UNKNOWN FEMORAL COMPONENT
• 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: 18625816
• MDR Text Key: 334347094
• Report Number: 0001825034-2024-00220
• Device Sequence Number: 1
• Product Code: JWH
• 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: Health Professional,Company Representative,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/16/2024

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 Model Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/11/2024
• Initial Date FDA Received: 02/01/2024
• Supplement Dates Manufacturer Received: 02/14/2024
• Supplement Dates FDA Received: 02/16/2024
• 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): Required Intervention; Hospitalization
• Patient Age: 75 YR
• Patient Sex: Female