MAUDE Adverse Event Report: BIOMET UK LTD. UNKNOWN COPELAND HUMERAL RESURFACING HEAD

Model Number N/A

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Initial report.Report source, foreign - event occurred in (b)(6).The product has been requested to be returned to zimmer biomet for an investigation.The investigation is currently underway.Once the investigation has concluded, a follow-up mdr will be submitted.

Event Description

It was reported, that: on 04 march 2022, a journal article was retrieved from the seminars in arthroplasty jses (2021) 31:3 (532-540) that reported a study from france.The main objective of this study was to evaluate the medium-term survival rate of shoulder resurfacing humeral arthroplasties (sra).The secondary objectives were to evaluate the clinical and radiological results and complications of this kind of arthroplasty.Sixty-five patients (75 shoulders) with a mean age of 69.1 years underwent shoulder resurfacing arthroplasty with the copeland humeral resurfacing head (zimmer-biomet orthopedic, warsaw, in, usa) for 41 shoulders, and the aequalis resurfacing humeral head (tornier, montbonnot, france) for 34 shoulders between 2003 and 2017.Radiographic factors were evaluated pre-and postoperatively on ap and lateral views and on a preoperative ct scan.At the last follow-up, functional results were evaluated using the constant score, disability arm shoulder and hand score (dash), pain on a numeric scale and active range-of-motion measurement.This study confirmed that sra is a good surgical option for shoulder arthroplasty with good survival rates and functional results, especially for patients with primary osteoarthritis.The study reports that one patient underwent a revision of the copeland humeral resurfacing head due to unknown reasons.Patient outcome: revision.

Manufacturer Narrative

(b)(4).This final report is being submitted to relay supplemental information.Complaint summary: the product has not been returned for evaluation.The item and lot number have not been provided.X-rays or medical notes have not been provided.The investigation has been limited to the information provided.A historical search could not be performed as the item and lot number have not been provided.This device is used for treatment not enough information has been provided to determine if all implants are compatible.A manufacturing history review or a review of recalls could not be performed as the item and lot number have not been provided.The likely condition of the device when it left zimmer biomet could not be determined as the item and lot number have not been provided.The root cause of the reported event cannot be determined with the information provided.No corrective action is required at this time as the root cause of the reported event has not been determined.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: on 04 march 2022, a journal article was retrieved from the seminars in arthroplasty jses (2021) 31:3 (532-540) that reported a study from france.The main objective of this study was to evaluate the medium-term survival rate of shoulder resurfacing humeral arthroplasties (sra).The secondary objectives were to evaluate the clinical and radiological results and complications of this kind of arthroplasty.Sixty-five patients (75 shoulders) with a mean age of 69.1 years underwent shoulder resurfacing arthroplasty with the copeland humeral resurfacing head (zimmer-biomet orthopedic, warsaw, in, usa) for 41 shoulders, and the aequalis resurfacing humeral head (tornier, montbonnot, france) for 34 shoulders between 2003 and 2017.Radiographic factors were evaluated pre-and postoperatively on ap and lateral views and on a preoperative ct scan.At the last follow-up, functional results were evaluated using the constant score, disability arm shoulder and hand score (dash), pain on a numeric scale and active range-of-motion measurement.This study confirmed that sra is a good surgical option for shoulder arthroplasty with good survival rates and functional results, especially for patients with primary osteoarthritis.The study reports that one patient underwent a revision of the copeland humeral resurfacing head due to unknown reasons.Patient outcome: revision.

• Brand Name: UNKNOWN COPELAND HUMERAL RESURFACING HEAD
• Type of Device: UNKNOWN COPELAND HUMERAL RESURFACING HEAD
• 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: 13709059
• MDR Text Key: 286919711
• Report Number: 3002806535-2022-00097
• Device Sequence Number: 1
• Product Code: HSD
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Literature
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN COPELAND HUMERAL
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/31/2022
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention