MAUDE Adverse Event Report: BIOMET UK LTD. OXF ANAT BRG RT MD SIZE 6 PMA; OXFORD HXLPE BEARINGS

Model Number N/A

Device Problems Use of Device Problem (1670); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem Insufficient Information (4580)

Event Date 09/08/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Initial report.Report source, foreign - event occurred in (b)(6).Concomitant medical devices: customer has indicated that the product will not be returned to zimmer biomet for investigation, as it remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Device remains implanted.

Event Description

It was reported that the implant expired (b)(6) 2021 but was implanted by the customer (b)(6) 2021.

Event Description

15 sep 2021 it was reported, that: "implant expired 2/9/21 was implanted by customer (b)(6) 2021".Patient involvement.Addi 24 sep 2021 (b)(6) the clinical support provided the following information :- the implant was on the ood list and the hospital aware.The member of staff who manages this had been off sick and the implant still on the shelf.The time line was within the month period (b)(6) says he has been set to remove ood¿s.The implant was erroneously implanted as the staff did not read the day/month/year, reading only month and year.(b)(6) as of 17th sept was unaware of the event being labelled adverse by the hospital but an investigation is ongoing into the event.We (qara) as we already explained to (b)(6), are raising a capa.Addi 27 sep 2021 this was a consignment item.The discovery was made post operation.There was no delay in surgery.+ picture attached addi 14 oct 2021 legal letter to complainant sent by (b)(6) to (b)(6) mailbox.

Manufacturer Narrative

(b)(4).This final report is being submitted to relay additional information.Complaint summary: the event reports an expired implant was implanted.No harm has been reported.Product has not been returned for evaluation.The expiry date has been confirmed to be 02 sept 2021 during the dhr review.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 number in the last 3 years and no additional complaints for the same item and lot combination.This device is used for treatment.Implant compatibility is not required as reported event is not related to a combination of implants.These part and lot combinations are not associated with any recalls at the time the search was conducted.The likely condition of the device when it left zimmer biomet is conforming to specification.The root cause of the reported event is use error.All implants are clearly labelled with the expiry date, and the ifu clearly indicates the implants should not be used after the expiry date.No corrective action required at this time.A letter provided by the research department concluded the following: in summary, while there is a theoretical risk that the bearing could be non-sterile, the absence of an infection (if this has been confirmed) would point to it being sterile.Similarly, the risk of oxidation is also expected to be negligible due to the bearing being manufactured using direct compression moulded uhmwpe, with argon-flushed, vacuum sealed, glass-lined packaging.Moreover, it should be noted that any theoretical risks are outweighed by those associated with carrying out a revision surgery.Based on this, we would therefore not suggest that any additional action is required apart from your continued routine clinical monitoring of the patient involved in line with the normal protocols employed by the responsible clinician.If any further information is found which would change or alter any conclusions or information, a supplemental will be submitted accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: OXF ANAT BRG RT MD SIZE 6 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: 12532349
• MDR Text Key: 273318685
• Report Number: 3002806535-2021-00404
• Device Sequence Number: 1
• Product Code: NRA
• UDI-Device Identifier: 05019279786244
• UDI-Public: 05019279786244
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P010014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/02/2021
• Device Model Number: N/A
• Device Catalogue Number: 159578
• Device Lot Number: 3860861
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/06/2016
• 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): Other