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

Model Number N/A

Device Problems Unstable (1667); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 03/16/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant products: unknown humeral stem cat#ni lot#ni; unknown humeral head cat#ni lot#ni.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2022 - 01377, 0001825034 - 2022 - 01378.

Event Description

It was reported that a patient underwent a revision procedure due to pain, limited function and rotator cuff failure.During the revision, scar tissue was noted, the stem was well fixed, and the head and glenoid were replaced without complication.Attempts have been made and additional information on the reported event is unavailable at this time.

Event Description

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

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Part and lot identification are necessary for review of device history records, neither were provided.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: pre-op workup for infection was negative.Pre-op xrays showed anterior superior escape of the shoulder.Scalene block with general anesthesia, ebl 100cc.Subdeltoid space development was tedious due to prior surgery and scar tissue present, the subscap really was not present.The stem was examined and found to be well fixed.No intraoperative complications noted.Pre-op and post-op diagnosis documented: instability of l prosthetic total shoulder.The product surveillance team received x-rays, however, they were not reviewed as the op notes confirmed the reported issues.A definitive root cause cannot 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
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 14685650
• MDR Text Key: 294008770
• Report Number: 0001825034-2022-01379
• Device Sequence Number: 1
• Product Code: HSD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/07/2022
• 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
• Patient Sequence Number: 1
• Treatment: SEE H10.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Male