MAUDE Adverse Event Report: ZIMMER GMBH ANATOMICAL SHOULDER¿¢ REVERSE, SCREW SYSTEM, 4.5-33; SHOULDER PROTHESIS

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Osteolysis (2377)
Date of Event	02/14/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Anatomical shoulderâ¿¢ reverse, screw system, 4.5-42; item# 0104223042; lot# 2720418 15mm post length base plate; item# 00434901500; lot# 62645037.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that a patient will have a revision for a patient matched implant due to glenoid bone loss.A vault reconstruction system may be required, and a revision has been planned.Due diligence has been completed for this complaint; to date no additional information or product has been received.
Event or Problem Description
It was reported that a patient had a revision surgery for a patient matched implant due to glenoid bone loss, approximately 10 years after initial implantation.The implants were removed and put in a spacer in to order the custom vrs.Subsequently, 4 months later the procedure was completed and the custom vrs was implanted.Due diligence has been completed for this complaint; to date all available additional information has been received.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: b2, b3, b5, d6b, g3, h2, h3, h6, h10 corrected: b1, d4, e1 the device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a follow-up mdr will be submitted.
Event or Problem Description
No additional event information at this time.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: g3; h2; h3; h6.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.A review of the device manufacturing records confirmed no abnormalities or deviations that could be related to the reported event.Review of the complaint histories found no additional related complaints for these items and the reported part and lot combinations.With the available information a definitive root cause could not 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.

• Brand Name: ANATOMICAL SHOULDER¿¢ REVERSE, SCREW SYSTEM, 4.5-33
• Common Device Name: SHOULDER PROTHESIS
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer (Section G): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 19476335
• Report Number: 0009613350-2024-00216
• Device Sequence Number: 12530781
• Product Code: KWS
• UDI-Device Identifier: 00889024286016
• UDI-Public: (01)00889024286016(17)180630(10)2707928
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K990136
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/03/2024

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: Lay User/Patient
• Device Expiration Date: 06/30/2018
• Device Model Number: N/A
• Device Catalogue Number: 0104223033
• Device Lot Number: 2707928
• 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: Not provided
• Supplement Date Received by Manufacturer: 08/12/2024; 09/02/2024
• Initial Report FDA Received Date: 06/06/2024
• Supplement Report FDA Received Date: 08/28/2024; 09/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/03/2013
• 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; Other; Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male