MAUDE Adverse Event Report: BIOMET UK LTD. COPELAND HA MED RESURF HD; SHOULDER PROTHESIS

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Erosion (1750)

Event Date 12/21/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).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 progress.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that a patient underwent an initial shoulder arthroplasty on an unknown date.Subsequently, a revision procedure due to severe glenoid wear/erosion was performed on (b)(6) 2021.Revised to pmi.

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.This device is used for treatment.The reported event is not related to a combination of products; therefore, a compatibility review is not applicable.A review of complaint history identified no similar complaints about the reported item and no additional complaints about the reported item and lot combination.Medical records or x-rays have not been provided.The likely condition of the device when it/they 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.No corrective or preventive action is required at this time.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

It was reported, that: revision of copeland implant - implant removed and comprehensive pmi implanted.Reason for revision - severe glenoid wear/erosion - resulting in no standard line implant being suitable for re-implantation hence the reason a pmi was required.(a per has been completed for this event on the 21st of december 2021 but it was combined with a per for another product/event occurring during the same surgery).Patient outcome: revision.It was reported, that: a patient underwent an initial shoulder arthroplasty on an unknown date.Subsequently, a revision procedure due to severe glenoid wear/erosion was performed on dec 21, 2021.Revised to pmi.

• Brand Name: COPELAND HA MED RESURF HD
• Type of Device: SHOULDER PROTHESIS
• 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: 13306889
• MDR Text Key: 284171166
• Report Number: 3002806535-2022-00016
• Device Sequence Number: 1
• Product Code: HSD
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: N/A
• 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: 04/28/2022

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 Model Number: N/A
• Device Catalogue Number: 114311
• Device Lot Number: 3567178
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/21/2021
• Initial Date FDA Received: 01/20/2022
• Supplement Dates Manufacturer Received: 04/27/2022
• Supplement Dates FDA Received: 04/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/22/2015
• 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): Hospitalization; Required Intervention