MAUDE Adverse Event Report: BIOMET UK LTD. OXF TRIAL BEARING MED SZ 4/5; KNEE ARTHROPLASTY

Model Number N/A

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/09/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4) initial report.Product has been requested to 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 the oxford trial instrument broke during surgery.No delay of the surgery reported.No harm of the patient or the user reported.

Event Description

It was reported that the oxford trial instrument broke during surgery.No delay of the surgery reported.No harm of the patient or the user reported.

Manufacturer Narrative

(b)(4).This final report is being submitted to relay additional information.The following sections were updated: b5, d9, h1, h2, h3, h6, h10 products have been returned to biomet uk ltd for evaluation and forwarded to the product evaluation complaints engineer for investigation.Review of the certificates of conformance from both the manufacturer (symmetry medical [othy]) and the raw material supplier (westlake plastics company) confirms that the material complies to required requirements of the specification.A review of the complaint database over the last 3 years has found 2 similar complaints reported for item 32-420378.There were (0) additional complaints against the lot 299608.The instrument has been in the field for some time, shows heavy signs of previous use and from the information currently available there is no evidence to suggest that the product left the company non-conforming to specification or regulatory compliance.The most likely root cause is expected wear and tear due to the time spent in the field (approximately 14 years).

• Brand Name: OXF TRIAL BEARING MED SZ 4/5
• Type of Device: KNEE ARTHROPLASTY
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 11371842
• MDR Text Key: 244802394
• Report Number: 3002806535-2021-00051
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 04/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 32-420378
• Device Lot Number: 299608
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Patient Weight: 258