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

Model Number N/A

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

Patient Problem Osteopenia/ Osteoporosis (2651)

Event Type  Injury  

Manufacturer Narrative

(b)(4).(udi): n/a.The customer has not indicated whether the product will be returned to zimmer biomet for investigation or not.Once this information is obtained a follow-up mdr will be submitted.

Event Description

It was reported that the patient underwent a right shoulder arthroplasty on an unknown date.Subsequently, the patient is planned to be revised due to glenoid bone loss.

Event Description

Upon receipt of additional information it has been determined that this device did not cause or contribute to the reported event.The following were found to likely contribute to the patient's reported event, previous history of bone deformity, dislocations, revisions, currently at 5 months¿ recovery of last revision, extreme muscle atrophy and weight loss as well as surgeon stating complications stemming from initial bone fractures and fall with dislocation.

Manufacturer Narrative

(b)(4).Upon receipt of additional information it has been determined that this device did not cause or contribute to the reported event.The following were found to likely contribute to the patient's reported event, previous history of bone deformity, dislocations, revisions, currently at 5 months¿ recovery of last revision, extreme muscle atrophy and weight loss as well as surgeon stating complications stemming from initial bone fractures and fall with dislocation.

• Brand Name: UNK HUMERAL HEAD
• Type of Device: PROSTHESIS SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10247426
• MDR Text Key: 198322853
• Report Number: 0001825034-2020-02677
• Device Sequence Number: 1
• Product Code: HSD
• 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,health
• Type of Report: Initial,Followup
• Report Date: 07/29/2020

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 Model Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/15/2020
• Initial Date FDA Received: 07/08/2020
• Supplement Dates Manufacturer Received: 06/24/2020
• Supplement Dates FDA Received: 08/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention