MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN COPELAND HUMERAL HEAD; SHOULDER, PROSTHESIS

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

Patient Problem Damage to Ligament(s) (1952)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Foreign source: (b)(6).Journal citation: murray, nicholas j., et al."medium-term rates of radiolucency after." shoulder&elbow, vol.0(0), 2020, pp.1-7, doi:10.1177/1758573219901122.It is unknown if product will be returning to zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up report will be submitted.

Event Description

On 29-oct-2020, a journal article was retrieved from shoulder & elbow (2020) that reported a single center retrospective study from bristol, uk that examined radiological outcomes of the "epoca" metal-backed glenoid component.The purpose of the study was to investigate periprosthetic radiolucency rates associated with an uncemented, metal-backed polyethylene glenoid component with medium-term results.The study reviewed forty-one (41) total shoulder arthroplasties (tsa).All patients underwent a deltopectoral approach with biceps tenodesis, insertion of a metal-backed polyethylene epoca component, and insertion of a humeral component from either epoca (synthes), conservative anatomic prosthesis (depuy), or copeland (biomet) shoulder systems.The study population had a mean age of 69 years at time of surgery (range 53-86 years).Follow-up was conducted with a mean of 5.5 years (range 3-8 years).The study reported that three patients underwent revision surgery due to cuff failure.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Device history record review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

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

• Brand Name: UNKNOWN COPELAND HUMERAL HEAD
• Type of Device: SHOULDER, PROSTHESIS
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10897842
• MDR Text Key: 218199641
• Report Number: 0001825034-2020-04199
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other