MAUDE Adverse Event Report: BIOMET UK LTD. RINGLOC-X 10 DEGREE ARCOM XL LINER 46/28MM (22); HIP PROSTHESIS

Model Number N/A

Device Problem Off-Label Use (1494)

Patient Problem Insufficient Information (4580)

Event Date 06/07/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).Foreign- poland.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

Event Description

It was reported that expired product has been implanted.Due diligence is in progress for this complaint; to date no additional information or product has been received.

Event Description

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

Manufacturer Narrative

(b)(4).No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record identified no deviations or anomalies during manufacturing.Medical records were not provided.The root cause of the reported issue is attributed to user error (implantation of device after expiry date).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.

• Brand Name: RINGLOC-X 10 DEGREE ARCOM XL LINER 46/28MM (22)
• Type of Device: HIP PROSTHESIS
• 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: 14942605
• MDR Text Key: 295404381
• Report Number: 3002806535-2022-00293
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 05019279112104
• UDI-Public: (01)05019279112104(17)220520(10)6061569
• 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: Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 08/23/2022

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/20/2022
• Device Model Number: N/A
• Device Catalogue Number: XL-062846
• Device Lot Number: 6061569
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/07/2022
• Initial Date FDA Received: 07/07/2022
• Supplement Dates Manufacturer Received: 07/28/2022
• Supplement Dates FDA Received: 08/23/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/20/2017
• 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