MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN GLENOID COMPONENT; PROSTHESIS SHOULDER

Model Number N/A

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

Patient Problems Pain (1994); Scar Tissue (2060); Muscle/Tendon Damage (4532)

Event Date 04/12/2011

Event Type  Injury  

Manufacturer Narrative

(b)(4).Implant date: unknown day in (b)(6) 2010.Medical product: catalog #: unknown, liner, lot # unknown; catalog #: unknown, head, lot # unknown.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as its location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2021-00863, 0001825034-2021-00864.Unknown location.

Event Description

It was reported that an initial left total shoulder arthroplasty was performed approximately 12 years ago.Subsequently, the patient underwent a two-stage revision due to infection.About a year later, the patient was reimplanted with an anatomic total shoulder.Then, another year later the patient was again revised due to rotator cuff failure, scar tissue, and pain.The humeral stem was left intact, and a reverse total shoulder was placed without complication.Attempts have been made and there is no further information at this time.

Event Description

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

Manufacturer Narrative

(b)(4) reported event was considered confirmed via medical record and x-rays which had extensive scar tissue noted, loose fragments of bone from the strut allograft and proximal humeral tuberosities.The pathology report states that the patient had a reaction the bone cement that was previously implanted device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.A definitive root cause could not be determined.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.

• Brand Name: UNKNOWN GLENOID COMPONENT
• Type of Device: PROSTHESIS SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11563817
• MDR Text Key: 242075657
• Report Number: 0001825034-2021-00862
• 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,consum
• Type of Report: Initial,Followup
• Report Date: 04/07/2021

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: 03/01/2021
• Initial Date FDA Received: 03/24/2021
• Supplement Dates Manufacturer Received: 04/07/2021
• Supplement Dates FDA Received: 04/08/2021
• 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
• Patient Weight: 95