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

Model Number N/A

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Bone Fracture(s) (1870); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Current information is insufficient to permit conclusions as to the cause of the events.Event details and product identification was not provided for the patients mentioned in the journal article.(b)(4).

Event Description

Information was received from a review of a journal article titled, "long-term follow up of the copeland mark iii shoulder resurfacing hemi-arthroplasty," which aimed to examine the long-term outcome of patients with the copeland mark iii humeral resurfacing hemi-arthroplasty.The study consisted of ninety-five (95) copeland hemi-arthroplasties performed in eighty-five (85) patients between 1994 and 2003.Sixty-five (65) patients were female and twenty (20) patients were male.Ages of patients ranged between thirty-five (35) and eighty-two (82), with follow-up occurring between 8.7 and 18 years.The journal article reports the following results: three (3) patients underwent revision procedures for peri-prosthetic fractures one (1) patient underwent open reduction and internal fixation due to peri-prosthetic fracture.The authors of this study conclude this long-term follow-up of the mark iii copeland resurfacing hemi-arthroplasty shows good results in an elderly population, with few complications and a low revision rate.

Manufacturer Narrative

This supplemental report is being submitted to address only one event of the article.The following fields have been updated with additional/ updated information.Customer has indicated that the product will not be returned to zimmer biomet for investigation.Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) 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.There are warnings in the package insert that this type of event can occur and risks are addressed in risk documentation.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.This report is being submitted late as it has been identified in remediation.

Event Description

This complaint is reporting the (b)(6) female patient shoulder revision due to peri-prostetic fracture event that was found in the article.There has been no further information provided and the patient outcome is unknown.

• Brand Name: UNKNOWN COPELAND RESURFACING SHOULDER
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 5476409
• MDR Text Key: 39557430
• Report Number: 0001825034-2016-00687
• Device Sequence Number: 1
• Product Code: MJT
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: PUNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/03/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 70 YR