MAUDE Adverse Event Report: ZIMMER BIOMET, INC. OSS REINFORCED YOKE; PROSTHEIS, 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 devices: 150392 - stem - 987470; 150351 - femoral - 289560; unknown poly; 00998604020 - trephine - 7198327.Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2020 - 02876.

Event Description

It was reported that the patient underwent an initial knee arthroplasty on an unknown date.Subsequently, the patient was revised due to femoral stem and hinge post fracture.Attempts have been made and no further information has been provided.

Event Description

The sales rep confirmed the lock pin fractured and not the yoke.Upon receiving additional information of the reported event, it was determined to be not reportable.The initial report should be voided.

Manufacturer Narrative

Upon receiving additional information of the reported event, it was determined to be not reportable.The initial report should be voided.

• Brand Name: OSS REINFORCED YOKE
• Type of Device: PROSTHEIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10454778
• MDR Text Key: 204409731
• Report Number: 0001825034-2020-03363
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: 00880304240094
• UDI-Public: (01)00880304240094(17)280128(10)113530
• Combination Product (y/n): N
• PMA/PMN Number: K052685
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 12/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2020
• 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: 150493
• Device Lot Number: 113530
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10.
• Patient Outcome(s): Hospitalization; Required Intervention