MAUDE Adverse Event Report: BIOMET UK LTD. RLOC-X ARCOMXL 10GR 60/36MM 26; ARCOM XL LINERS HXLPE

Model Number N/A

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem Insufficient Information (4580)

Event Date 09/09/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Initial report.Report source, foreign - event occurred in europe: (b)(6).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.

Event Description

It was reported that the product with expiration date 08 august 2021 was implanted on (b)(6) 2021.

Manufacturer Narrative

(b)(4).This final report is being submitted to relay additional information.Complaint summary: the event reports an expired implant was implanted.The implant was implanted 32 days past the expiry date.No harm has been reported.Product has not been returned for evaluation.The expiry date has been confirmed to be 08 aug 2021 during the dhr review.X-rays or medical notes have not been provided.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 vitamin e-infused 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.

Event Description

It was reported that the product with expiration date 08 august 2021 was implanted on (b)(6) 2021.

• Brand Name: RLOC-X ARCOMXL 10GR 60/36MM 26
• Type of Device: ARCOM XL LINERS HXLPE
• 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: 12538994
• MDR Text Key: 273539519
• Report Number: 3002806535-2021-00405
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 12/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/08/2021
• Device Model Number: N/A
• Device Catalogue Number: XL-063660
• Device Lot Number: 3857958
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/09/2021
• Initial Date FDA Received: 09/28/2021
• Supplement Dates Manufacturer Received: 12/15/2021
• Supplement Dates FDA Received: 12/15/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/16/2016
• 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