MAUDE Adverse Event Report: ZIMMER BIOMET, INC. STANDARD 40MM DIAMETER BEARING; SHOULDER, PROSTHESIS

Catalog Number	110031421
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Naturally Worn (2988)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/15/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Cmp-(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2023 -03609.D10: mini standard thickness +6mm taper offset 40mm diameter humeral tray cat: 110031405 lot: 65172673.G2: foreign: canada.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up report will be submitted.H3 other text : product not returned.
Event or Problem Description
It was reported that the patient was revised due to instability.Upon examination and current xray, it was noted that the reverse liner had disassociated from its tray and was the cause the instability.No additional patient consequences were reported.Attempts have been made and additional information on the reported event is unavailable.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: d1, d2, d4, d9, g4, h4 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 or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.A comprehensive reverse shoulder poly bearing and a comprehensive reverse shoulder mini humeral tray were returned for evaluation.As returned, damage is seen on the backside and spherical radius of the bearing.The locking tabs are bent/damaged.The inner humeral tray exhibits surface damage.Medical records/radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: a reverse-type right shoulder arthroplasty is present.There is superior displacement of the polyethylene liner with resulting mild subluxation of the glenohumeral alignment and metal on metal implant contact.There is no fracture.Device history record was reviewed and no discrepancies were found.The reported event is confirmed, based on review of the provided x-rays.Root cause was unable to 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.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: STANDARD 40MM DIAMETER BEARING
• Common Device Name: SHOULDER, PROSTHESIS
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 18320654
• Report Number: 0001822565-2023-03607
• Device Sequence Number: 15236205
• Product Code: KWS
• UDI-Device Identifier: 00887868231520
• UDI-Public: (01)00887868231520(17)260526(10)65007451
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K181611
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/24/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/26/2026
• Device Catalogue Number: 110031421
• Device Lot Number: 65007451
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/20/2023
• Supplement Date Received by Manufacturer: 01/02/2024; 04/02/2024
• Initial Report FDA Received Date: 12/13/2023
• Supplement Report FDA Received Date: 01/24/2024; 04/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/15/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Male