MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ZIMMER TRABECULAR METAL REVERSE TOTAL SHOULDER SYSTEM POLY LINER; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number	00434904003
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	04/25/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent a right shoulder arthroplasty approximately two (2) years and four (4) months ago.Subsequently, the patient was revised approximately one (1) year and four (4) months later due to dislocation.The patient was fitted with thicker components to strengthen component connections during the revision, and no other harms were reported due to this event.Attempts have been made, and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).D10: concomitant medical products, part (lot): ¿ unknown glenosphere - (unknown).Associated product information: ¿ 00434901813 - (64640907); ¿ 00434903912 - (62748666); ¿ 00436202000 - (64414277).The customer has indicated that the product will not be returned to zimmer biomet for investigation as the product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.If any further information is found that would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4; b5; d2; g1; g3; g6; h1; h2; h3; h6; h10 the reported event is not confirmed.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.A review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.Medical records were not provided.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: ZIMMER TRABECULAR METAL REVERSE TOTAL SHOULDER SYSTEM POLY LINER
• Common Device Name: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• 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: 19255239
• Report Number: 0001822565-2024-01486
• Device Sequence Number: 6381264
• Product Code: PHX
• UDI-Device Identifier: 00889024269149
• UDI-Public: (01)00889024269149(17)290227(10)64812457
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K130661
• 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: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/31/2024

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 Catalogue Number: 00434904003
• Device Lot Number: 64812457
• Was Device Available for Evaluation?: No
• 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: 04/11/2024
• Supplement Date Received by Manufacturer: 07/18/2024
• Initial Report FDA Received Date: 05/06/2024
• Supplement Report FDA Received Date: 07/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2021
• 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: H11.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown