MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP RVS CNTRL 6.5X30MM ST/RST; SHOULDER PROSTHESIS, REVERSE CONFIGURATION/EXTREMITIES

Catalog Number	115396
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/08/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: medical products: item#: 113632, comp primary stem 12mm mini; lot#: 66335967 item#: 115310, comp rvrs shldr glnsp std 36mm; lot#: 625110 item#: 180560, comp nlk scr 3.5hex 4.75x30 st; lot#: 66008695 item#: 180560, comp nlk scr 3.5hex 4.75x30 st; lot#: 66008695 item#: 010000589, comp rvrs 25mm bsplt ha+adptr; lot#: 66450519 item#: 66450519, mini standard thickness +0mm taper offset 40mm diameter humeral tray; lot#: 66653185 item#: 110031418, standard 36mm diameter bearing; lot#: 66259457 h3: 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.
Event or Problem Description
It was reported that the patient underwent an initial shoulder arthroplasty approximately eleven (11) months ago.Subsequently, there has been an alleged unknown complication with no known intervention to date.Attempt has been made to obtain additional information.No additional information has been received at this time.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: a1; a4; b4; b5; b7; d2; g2; g3; g6; h1; h2; h6.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that the patient underwent an initial right reverse total shoulder arthroplasty approximately one (1) year and three (3) months ago.Subsequently, the patient underwent a revision surgery approximately a month and a half after their intial surgery due to a mechanical failure of the glenosphere.No further information has been provided at this time.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional and corrected information.The following sections were updated: b4; b5; d2; g2; g3; g6; h1; h2.Upon receipt of additional information, it was determined this product was not the cause of the event.The initial report should be voided.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: COMP RVS CNTRL 6.5X30MM ST/RST
• Common Device Name: SHOULDER PROSTHESIS, REVERSE CONFIGURATION/EXTREMITIES
• 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: 22370775
• Report Number: 0001825034-2025-01918
• Device Sequence Number: 17240477
• Product Code: PHX
• UDI-Device Identifier: 00880304677081
• UDI-Public: (01)00880304677081(17)340426(10)66665365
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K132239
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/13/2025

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
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 115396
• Device Lot Number: 66665365
• 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: 06/05/2025
• Supplement Date Received by Manufacturer: 09/24/2025; 11/07/2025
• Initial Report FDA Received Date: 07/01/2025
• Supplement Report FDA Received Date: 10/22/2025; 11/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/26/2024
• 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 H11 NARRATIVE.
• Outcome Attributed to Adverse Event: Required Intervention; Other; Hospitalization
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 90 KG