MAUDE Adverse Event Report: ZIMMER BIOMET, INC. OSS AVL MOD TIB PLATE OSS TAPE PROSTHESIS, KNEE

Model Number N/A

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Failure of Implant (1924); Pain (1994)

Event Date 08/14/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4). Multiple mdr reports were filed for this event, please see associated report: 0001825034-2021-01278, 0001825034-2021-01279, 0001825034-2021-01281, 0001825034-2021-01282, 0001825034-2021-01283, 0001825034-2021-01284. Medical product: oss avl tibial lock ring, item# 161073, lot# 466660. Oss avl yoke 12mm, item# 161075, lot# 382130. Oss avl tib bearing 12mm, item# 161068, lot# 809890. Oss tib blk aug 10x63/67 univ, item# 150426, lot# 105590. Oss avl poly tib bushing set, item# 161071, lot# 490920. Oss poly femoral bushings, item# 150477, lot# 499870. Customer 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.

Event Description

It was reported that a patient was revised approximately five months¿ post-implantation due to locking nut fractured in two pieces and allowed piston to disengage from the tibial component. Attempts to obtain additional information have been made; however, no more information is available.

• Brand Name: OSS AVL MOD TIB PLATE OSS TAPE
• 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: 11739335
• MDR Text Key: 247769359
• Report Number: 0001825034-2021-01280
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051570
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,distributor,health p

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 05/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 05/17/2021
• Device Model Number: N/A
• Device Catalogue Number: 161065
• Device Lot Number: 690080
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 05/19/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/17/2016
• 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 Treatment Data

Date Received: 04/28/2021 Patient Sequence Number: 1