MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN OSS LOCK PIN; PROSTHESIS, KNEE

Model Number N/A

Device Problem Fracture (1260)

Patient Problems Pain (1994); Osteolysis (2377); Reaction (2414)

Event Date 07/06/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: associated products : item# 150392; oss porous im stem 13.5 x 150; lot# 987470.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2020-02876.The lock pin was not returned or pictures provided; visual and dimensional evaluations could not be performed.Reported event was confirmed by review of medical records.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Medical records were provided and reviewed by a heath care professional.Review found patient had pain, difficulty with activities of daily living including getting out of a chair, ambulating distances and stairs.X-rays show femoral stem fracture.Intra-op notes found the lock pin was also broken and evidence of metallosis in the knee tissue and synovium.Femoral component was grossly loose and easily removed with significant amount of osteolysis.Tibia was well fixed.No complications noted.Root cause cannot be determined.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.

Event Description

It was reported that the patient underwent an initial left knee arthroplasty on an unknown date.Subsequently, the patient was revised as the femoral stem and locking pin broke.

• Brand Name: UNKNOWN OSS LOCK PIN
• 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: 11100271
• MDR Text Key: 224523702
• Report Number: 0001825034-2020-04459
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/30/2020

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
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/28/2020
• Initial Date FDA Received: 12/31/2020
• 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): Hospitalization; Required Intervention