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

Model Number N/A

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant products: unk baseplate 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: 0001822565 - 2022 - 01275.

Event Description

It was reported that a patient has been indicated for a revision procedure due to disassociation.No revision has been reported to date.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, g3, g6, h2, h3, h6, h10 h6 component code: mechanical (g04) ¿ head no product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record(s) for part 00436003600 identified no deviations or anomalies during manufacturing.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: three views of the right shoulder demonstrate a reverse total shoulder arthroplasty with possible disassociation of the glenosphere from the glenoid plate.No dislocation.No fracture.Normal bone quality.It was identified that during the procedure an incorrect impactor was used; however, after further review with development it was determined that this did not cause or contribute to the disassociation reported.Therefore the root cause for the reported event remains unknown.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 is available at the time of this report.

• Brand Name: UNKNOWN REVERSE GLENOSPHERE
• 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: 14277895
• MDR Text Key: 290659327
• Report Number: 0001822565-2022-01274
• 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: 06/30/2022

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?: 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
• Initial Date Manufacturer Received: 04/08/2022
• Initial Date FDA Received: 05/04/2022
• Supplement Dates Manufacturer Received: 05/03/2022
• Supplement Dates FDA Received: 06/30/2022
• 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
• Patient Outcome(s): Other
• Patient Sex: Female