MAUDE Adverse Event Report: ZIMMER GMBH ANATOMICAL SHOULDER¿¢, HUMERAL STEM, UNCEMENTED, ø 10.5, 100 MM; PROSTHESIS, EXTREMITY

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Tissue Breakdown (2681)
Date of Event	10/13/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported according to a clinical study that the patient was implanted with an anatomic total shoulder implant on the right side.A conversion to a reverse shoulder arthroplasty has been performed approximately 3 and a half years post implantation due to a rotator cuff insufficiency.Diligence is completed and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
(b)(4).G2.Report source: switzerland.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0009613350-2023-00719.0009613350-2023-00720.0009613350-2023-00721.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The rotator cuff is a group of muscles and tendons that surround the shoulder joint, keeping the head of the humerus firmly within the shallow socket of the shoulder.Rotator cuff injuries occur most often in people who repeatedly perform overhead motions or experience any sort of trauma to the shoulder.Degenerative tears can also occur because of gradual wearing down of the tendon.This degeneration naturally occurs as we age.Factors that lead to degenerative tears include repetitive stress, lack of blood supply, bone spurs, and increased age.Common symptoms of a rotator cuff tear include pain at rest or with activity, weakness, and crepitus.Typically, an anatomic shoulder is performed when the rotator cuff is stable and intact, and a reverse shoulder is performed for an insufficient rotator cuff.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.Multiple mdr reports were filed for this event, please see associated reports: 0009613350-2023-00719-1, 0009613350-2023-00720-1, 0009613350-2023-00721-1.
Event or Problem Description
Diligence is completed and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.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
Diligence is completed and no additional information on the reported event is required at this time.

• Brand Name: ANATOMICAL SHOULDER¿¢, HUMERAL STEM, UNCEMENTED, ø 10.5, 100 MM
• Common Device Name: PROSTHESIS, EXTREMITY
• 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: 18397561
• Report Number: 0009613350-2023-00718
• Device Sequence Number: 2759930
• Product Code: KWS
• UDI-Device Identifier: 00889024484917
• UDI-Public: (01)00889024484917(17)220930(10)2923836
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K160085
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/23/2024

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 09/30/2022
• Device Model Number: N/A
• Device Catalogue Number: 0104201103
• Device Lot Number: 2923836
• 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: 11/30/2023
• Supplement Date Received by Manufacturer: 01/03/2024; 04/26/2024
• Initial Report FDA Received Date: 12/27/2023
• Supplement Report FDA Received Date: 01/17/2024; 05/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/12/2017
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Weight: 107 KG