MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH ANATOMICAL SHOULDER REVERSE, SCREW SYSTEM, 4.5-42; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number	N/A
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Joint Dislocation (2374); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10 - medical devices: 40mm glenosphere; item# 00434904011; lot# 65243512.12mm humeral stem spacer; item# 00434903912; lot# 65473774.14mm 130mm length humeral stem; item# 00434901413; lot# 65242785.40mm +6mm offset 65 neck angle retentive poly liner; item# 00434906606; lot# 64759532.+2mm lateral offset 25mm post length base plate; item# 00434902502; lot# 64759472.Anatomical shoulder reverse, screw system, 4.5-48; item# 01.04223.048; lot# 2940206.Multiple mdr reports were filed for this event, please see associated reports: 0009613350-2023-00513.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a supplemental medwatch 3500a will be submitted.
Event or Problem Description
It was reported that the patient is being considered for a shoulder revision due to unknown reasons.No additional patient consequences were reported.Due diligence is in progress for this complaint; to date no additional information or product has been received.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.It was reported a the patient is being considered for a shoulder revision due to dislocation.It was noted that the patients components are maxed out on length so the patient will be revised using competitor products.No products were returned or pictures provided; visual and dimensional evaluations could not be performed.A review of the device manufacturing records confirmed no abnormalities or deviations.Devices are used for treatment.One radiographic image of the right shoulder was provided and reviewed by a radiologist with the following assessment: single view of the right shoulder demonstrates a reverse total shoulder arthroplasty without radiolucency.No fracture.No dislocation.Overall fit and alignment of the implant is normal.Normal bone quality.No further medical records were provided.Based on the review of the radiographic image, the reported event cannot be confirmed.It is noted that the patient's components are maxed out on length, which is why the patient is being considered for revision due to dislocation.However, based on the given information and results of the investigation, 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
It was reported that the patient is being considered for a shoulder revision due to dislocations.Patient requires custom made implant.No additional patient consequences were reported.

• Brand Name: ANATOMICAL SHOULDER REVERSE, SCREW SYSTEM, 4.5-42
• Common Device Name: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer (Section G): ZIMMER SWITZERLAND MANUFACTURING 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: 17727931
• Report Number: 0009613350-2023-00514
• Device Sequence Number: 6134832
• Product Code: KWS
• UDI-Device Identifier: 00889024483057
• UDI-Public: (01)00889024483057(17)260901(10)3082070
• 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: 2021
• 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
• Report Date (Section B): 10/06/2023

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: 09/01/2026
• Device Model Number: N/A
• Device Catalogue Number: 01.04223.042
• Device Lot Number: 3082070
• 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: 08/16/2023
• Supplement Date Received by Manufacturer: 09/20/2023
• Initial Report FDA Received Date: 09/12/2023
• Supplement Report FDA Received Date: 10/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2021
• 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
• 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: Required Intervention
• Patient Sex: Male