MAUDE Adverse Event Report: BIOMET UK LTD. UNKNOWN OXFORD BEARING

Model Number N/A

Device Problems Break (1069); Fracture (1260); Material Integrity Problem (2978)

Patient Problems Failure of Implant (1924); Implant Pain (4561)

Event Date 04/10/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Initial report.The product has been requested to be returned to zimmer biomet for an investigation but currently remains implanted.The option for a revision surgery will be discussed on 28th march.Further information may become available so product return cannot be ruled out.Multiple mdr reports were filed for this event, please see associated report numbers: 3002806535-2022-00156 and 3002806535-2022-00157.The investigation is currently underway.Once the investigation has concluded, a follow-up mdr will be submitted.

Event Description

It was reported that: (b)(6) received a left oxford partial knee implant in (b)(6) 2021 by dr (b)(6).He participated in rehab but his knee never healed with constant pain.The pain increased after surgery in comparison to before receiving the implant.Last saturday(b)(6) 2022 he received x-rays at (b)(6) hospital and was informed the implant had come apart.He will be returning to the hospital on (b)(6) 2022 to discuss a revision surgery.He assumed it was age-related but x-rays have confirmed knee implant came apart.Patient involved.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Adequate photographs have not been provided and product the has not been returned for evaluation.Therefore, the investigation has been limited to the information provided.Reported event was unable to be confirmed.Device history record (dhr) review was unable to be performed as the item and lot number of the device involved in the event is unknown.Root cause could not 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 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 OXFORD BEARING
• Type of Device: UNKNOWN OXFORD
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• Manufacturer (Section G): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 13860399
• MDR Text Key: 289505163
• Report Number: 3002806535-2022-00158
• Device Sequence Number: 1
• Product Code: NRA
• 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: Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2022
• 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 OXFORD BEARING
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 53 YR
• Patient Sex: Male