MAUDE Adverse Event Report: ZIMMER GMBH INVERS/REVERS SCR SYST 4.5-36; IMPLANT, TRAUMA

Catalog Number	0104223036
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	04/04/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: invers/revers scr, #item: 0104223036, #lot: 2823876.Tm rvs base plt, #item: 00-4349-015-00, #lot: 63799890.36mm vit e liner +0mm, #item: 00-4350-036-00, #lot: 64054234.Therapy date : (b)(6) 2025.G2: foreign report source japan.Attempts have been made to gather all product identification information, and no further information has been provided.An investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Event or Problem Description
It was reported that the patient underwent a revision approximately 6 years post-implantation due to pain and tmr loosening.Attempts have been made and all available information has been provided.
Event or Problem Description
No additional event information.
Additional Manufacturer Narrative
Follow up report (b)(4).Updated:b4,b5,d2,g1,g3,g6,h1,h2,h3,h6 no product was returned or pictures provided; a product evaluation could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing.Review of the complaint histories identified additional similar complaints for the reported items and no additional similar complaints for the reported part and lot combinations.Complaints are monitored per complaint trending process in order to identify potential adverse trends.Medical records were provided and reviewed by a health care professional.Review of the available the information provided for this reported event refers a tendency of dislocation of the shoulder implant and pain.The screws reported in this complaint are not involved in the dislocation event, but their involvement in the onset of pain cannot be excluded.Based on the available information, a relation between the onset of pain and the involvement of the screw cannot be confirmed, and a definitive root cause for the reported event cannot be established.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: INVERS/REVERS SCR SYST 4.5-36
• Common Device Name: IMPLANT, TRAUMA
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur
• Manufacturer (Section G): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 22020005
• Report Number: 0009613350-2025-00373
• Device Sequence Number: 8779031
• Product Code: PHX
• UDI-Device Identifier: 00889024483040
• UDI-Public: (01)00889024483040(17)230331(10)2937875
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K052906
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2025
• 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
• Report Date (Section B): 07/14/2025

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 Expiration Date: 03/31/2023
• Device Catalogue Number: 0104223036
• Device Lot Number: 2937875
• 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: 04/24/2025
• Supplement Date Received by Manufacturer: 07/04/2025
• Initial Report FDA Received Date: 05/14/2025
• Supplement Report FDA Received Date: 07/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/20/2018
• 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: Hospitalization; Required Intervention
• Patient Sex: Unknown