MAUDE Adverse Event Report: BIOMET UK LTD. OXFORD TRIAL BRNG LRG SZ 4/5; BMET GENERAL KNEE INSTRUMENTS

Model Number N/A

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

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/11/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Initial report.Concomitant medical products:: customer has indicated that the product is in process of being 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 poly trial bearing cracked and is loose.

Event Description

It was reported that the poly trial bearing cracked and is loose.

Manufacturer Narrative

(b)(4).This final report is being submitted to relay additional information.Products have been returned to biomet uk ltd for evaluation and forwarded to the product evaluation complaints engineer for investigation.The devise is used for treatment.Review of returned product confirms the reported event.Visual inspection of the returned instrument shows that the 4mm trial bearing has fractured at the point where the handle fits the trial bearing.General wear & tear is evident and is expected due to repeated use during its time in the field (approximately 4 years and 6 months).Dimensional check was not carried out as dimensional non-conformance does not have any impact on the reported event.No assembly checks were carried out as returned product was damaged.A review of the raw material certificates (item# 32-420382-00 lot# 148883 rir) from ensinger confirms that the material used to produce the instruments were conforming to standards and specification prior to shipment to zb.A review of the manufacturing history record (item# 32-420382 lot# 497520 dhr) shows that all parts were manufactured and verified as conforming to specification and quality characteristics as defined by zimmer biomet.The product item no.32-420382 batch 497520 has not been involved in any previous field actions the root cause cannot be determined with the available information however, the likely root cause of the reported event is damage caused by repeated use during repeated use and time spent in the field (approximately 4 years and 6 months) or damage during reprocessing.No corrective actions are required at this time.

• Brand Name: OXFORD TRIAL BRNG LRG SZ 4/5
• Type of Device: BMET GENERAL KNEE INSTRUMENTS
• 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: 12826547
• MDR Text Key: 281982274
• Report Number: 3002806535-2021-00499
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 05019279483891
• UDI-Public: 05019279483891
• 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: User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 32-420382
• Device Lot Number: 497520
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/11/2021
• Initial Date FDA Received: 11/17/2021
• Supplement Dates Manufacturer Received: 02/03/2022
• Supplement Dates FDA Received: 02/04/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1