MAUDE Adverse Event Report: BIOMET UK LTD. OXF ANAT BRG LT MD SIZE 3 PMA; OXFORD HXLPE BEARINGS

Model Number N/A

Device Problems Manufacturing, Packaging or Shipping Problem (2975); Appropriate Term/Code Not Available (3191)

Patient Problem Insufficient Information (4580)

Event Date 04/14/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).Initial report.Report source, foreign - event occurred in (b)(6).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 revision took place to remove the implant because the reference indicated on the package label is the wrong reference; the reference was for size 3m, whereas on the implant it is indicated size 3l (the lot number on the label and engraved on the implant is the same).

Event Description

It was reported, that: a revision to remove the implant because the reference indicated on the package label is the wrong reference; the reference was for size 3m, whereas on the implant it is indicated size 3l (the lot number on the label and engraved on the implant is the same).

Manufacturer Narrative

(b)(4).This final report is being submitted to relay supplemental information.Complaint summary: 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, a review of the device history records, and a complaint history search.A review of the device history records identified no deviations or anomalies during manufacturing that could be related to the reported event.A review of the drawing for item 159547 shows that it should be engraved 3 l which indicates size 3 left medial.A review of the package label attached to the dhr for lot # 6742018 shows it is correctly printed with lm (left medial) medium size 3.This device is used for treatment.A review of complaint history identified no additional similar complaints about the reported item and no additional complaints about the reported item and lot combination.Medical records or x-rays are not relevant for this event.The likely condition of the device when it left zimmer biomet is conforming to the specification.The reported event has not been confirmed as relevant photographs have not been provided and the product 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.It has been confirmed that the implant is not within the scope or subject of any field actions or recalls which could be attributed to the reported event.Corrective or preventative action is not required.The root cause of the reported event cannot be determined with the information provided.If any additional information is discovered or received that may adjust any conclusions or data, a supplemental report will be rendered accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional and/or corrected information.D10: oxf uni cmntls tib sz c lm; catalog#166574; lot#unknown.Oxford ph3 cementless fem sz m; catalog#154926; lot#unknown.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional and/or corrected information.Adequate photographs have not been provided and although multiple attempts performed for getting product returned, it has not been returned for evaluation.No change to investigation as no product was returned or pictures provided; visual and dimensional evaluations could not be performed.If any further information is found which would change or alter any conclusions or information, a supplemental report 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: OXF ANAT BRG LT MD SIZE 3 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: 14248686
• MDR Text Key: 290446300
• Report Number: 3002806535-2022-00236
• Device Sequence Number: 1
• Product Code: NRA
• UDI-Device Identifier: 05019279785933
• UDI-Public: (01)05019279785933(17)250203(10)6742018
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P010014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 159547
• Device Lot Number: 6742018
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/03/2020
• 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 Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization