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

Model Number N/A

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

Patient Problem Erosion (1750)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Initial report.Report source, foreign - event occurred in the (b)(6).The device is currently still implanted in the patient, it is unknown if the device will be explained and therefore it cannot be confirmed if the device will be evaluated.The investigation is currently underway.Once the investigation has concluded, a follow-up mdr will be submitted.

Event Description

On (b)(6) 2022, it was reported, that the patient underwent a copeland resurfacing hemiarthroplasty on an unknown date.Subsequently, the patient suffered bone loss/ erosion and bone/ joint disease.The surgeon plans a custom pmi baseplate for comprehensive reverse shoulder replacement.Planned surgery date: (b)(6) 2022.Patient outcome: serious injury.

Event Description

It was reported, that: the patient underwent a copeland resurfacing hemiarthroplasty on an unknown date.Subsequently, the patient suffered bone loss/ erosion and bone/ joint disease.The surgeon plans a custom pmi baseplate for comprehensive reverse shoulder replacement.Planned surgery date: (b)(6) 2022.Patient outcome: serious injury.Addi 28 feb 2022.Copeland resurfacing hemiarthroplasty.Lot 2837355 product ref 114311.Surgeon for the initial procedure consultant mr (b)(6).The hospital was the initial procedure performed (b)(6) hospital.An initial procedure performed (b)(6) 2013 patient information: average sized patient.Average bone quality.No history of trauma.

Manufacturer Narrative

(b)(4).This follow-up document is being submitted to relay supplemental information.The investigation is currently underway.Once the investigation has concluded, a follow-up mdr will be tendered.

Event Description

It was reported, that: the patient underwent a copeland resurfacing hemiarthroplasy on an unknown date.Subsequently, the patient suffered bone loss/ erosion and bone/ joint disease.The surgeon plans a custom pmi baseplate for comprehensive reverse shoulder replacement.Planned surgery date: (b)(6) 2022.Patient outcome: serious injury.

Manufacturer Narrative

(b)(4).This final report is being submitted to relay supplemental information.Complaint summary: the product has not been returned for evaluation, therefore the investigation has been limited to the information provided.A dhr review could not be performed as the lot number has not been provided.A review of complaint history could not be carried out as item and lot numbers have not been provided.The device is used for treatment.X-rays or medical notes have not been provided.Without the opportunity to examine the complaint item, a definitive root cause cannot be determined due to insufficient information.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.

Manufacturer Narrative

(b)(4).This final report is being submitted to relay supplemental information.The following sections were updated: b4, b5, g3, g6, h1, h2, h6, h10.Complaint summary: the product has not been returned for evaluation, therefore the investigation has been limited to the information provided.A dhr review identified no deviations or anomalies during manufacturing that could be related to the reported event.A review of complaint history identified no additional similar complaints about the reported item number, and no additional complaints for the same item and lot combination for 3 years prior to the notification date the device is used for treatment.X-rays or medical notes have not been provided.Without the opportunity to examine the complaint item, a definitive root cause cannot be determined due to insufficient information.The investigation is completed based on currently available information.If any additional information becomes available, then the complaint will be reopened and further investigated.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

On 03 feb 2022, it was reported, that the patient underwent a copeland resurfacing hemiarthroplasty on an unknown date.Subsequently, the patient suffered bone loss/ erosion and bone/ joint disease.The surgeon plans a custom pmi baseplate for comprehensive reverse shoulder replacement.Planned surgery date: (b)(6) 2022.Patient outcome: serious injury.Addi 28 feb 2022 - copeland resurfacing hemiarthroplasty - item: 114311 - lot: 2837355 - surgeon for the initial procedure consultant mr h williams - the hospital was the initial procedure performed at clifton park hospital york - an initial procedure was performed on 09/07/2013 - patient information: average sized patient.Average bone quality.No history of trauma.

• Brand Name: COPELAND HA MED RESURF HD
• Type of Device: COPELAND HA HEADS
• 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: 13513098
• MDR Text Key: 286673119
• Report Number: 3002806535-2022-00066
• 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,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/30/2022

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2022
• Device Model Number: N/A
• Device Catalogue Number: 114311
• Device Lot Number: 2837355
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/03/2022
• Initial Date FDA Received: 02/11/2022
• Supplement Dates Manufacturer Received: 02/28/2022; 03/10/2022; 03/10/2022
• Supplement Dates FDA Received: 03/03/2022; 03/10/2022; 03/30/2022
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Age: 85 YR
• Patient Sex: Male