MAUDE Adverse Event Report: BIOMET UK LTD. OXF ANAT BRG RT MD SIZE 4 PMA; OXFORD HXLPE BEARINGS

Model Number N/A

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

Patient Problem Insufficient Information (4580)

Event Date 08/01/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Initial report.Report source, foreign - event occurred in (b)(6).Concomitant medical products: customer has indicated that the product will not be returned to zimmer biomet for investigation, as its location is unknown.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 bearing fractured.No further information in available at this time.

Event Description

It was reported that the oxford bearing fractured.No further information in available at this time.

Manufacturer Narrative

(b)(4).This final report is being submitted to relay additional information.Complaint summary: adequate photographs have not been provided and product has not been returned for evaluation.Therefore, the investigation has been limited to the information provided, a review of the device history records, and a complaint history search.Review of the device history records identified no deviations or anomalies during manufacturing that could be related to the reported event.Review of complaint history identified no additional similar complaints for the reported item and no additional complaints for the reported item 650-1055 and lot 3062797 combination.These devices are used for treatment.The reported event is not related to a combination of products; therefore, a compatibility review is not applicable.These part and lot combinations are not associated with any recalls at the time the search was conducted.The likely condition of the devices when it left zimmer biomet is conforming to specification.The reported event has not been confirmed as relevant photographs have not been provided and packaging has not been returned for evaluation and the dhr review did not identify any issues.The root cause of the reported event cannot be determined with the information provided.Corrective or preventative action not required.The root cause of the reported event cannot be determined with the information provided.The investigation is completed based on current available information.If any additional information becomes available, then the complaint will be reopened and further investigated.H3 other text : device location unknown.

• Brand Name: OXF ANAT BRG RT MD SIZE 4 PMA
• Type of Device: OXFORD HXLPE BEARINGS
• 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: 12553274
• MDR Text Key: 274001649
• Report Number: 3002806535-2021-00424
• Device Sequence Number: 1
• Product Code: NRA
• UDI-Device Identifier: 05019279786220
• UDI-Public: 05019279786220
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P010014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/11/2012
• Device Model Number: N/A
• Device Catalogue Number: 159576
• Device Lot Number: 1291789
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/13/2007
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 72 YR
• Patient Sex: Male