MAUDE Adverse Event Report: ZIMMER GMBH ANATOMICAL SHOULDER¿¢ REVERSE, SCREW SYSTEM, 4.5-18; PROSTHESIS, SHOULDER

Model Number	N/A
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Joint Dislocation (2374)
Date of Event	10/18/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: 00436201500 ¿ baseplate ¿ 66297134; 00436504000 ¿ glenosphere ¿ 64493954; unknown competitor cement ¿ unknown part and lot; unknown stem ¿ unknown part and lot.G3: report source japan.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.
Event or Problem Description
It was reported that a patient suffered a shoulder dislocation approximately 3 days post implantation and underwent a revision surgery approximately 2 weeks later.During the surgery, it was found that the cemented baseplate had fallen out of the glenoid.All implants except the stem were removed and replaced.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
(b)(4).No product was returned or pictures provided; visual and dimensional evaluations could not be performed.A review of all relevant device manufacturing records confirmed for both lots no abnormalities or deviations.Review of the complaint history (with both lots) found no additional related complaints for these items and the reported part and lot combinations.Radiographs were provided and reviewed by a health care professional/radiologist.Assessment of imaging: immediate post-op image demonstrates anatomic alignment of a reverse-type left shoulder arthroplasty."paperwork" image demonstrates interval loosening and displacement of the glenoid implant.The glenosphere appears disassociated from the baseplate with resulting glenohumeral subluxation."(b)(6) 2024 - (b)(6) 2024" images show interval revision with a cemented glenoid implant and multiple metallic pin fragments at the anterosuperior glenoid.On one ap image, the components are anatomically aligned.On the second ap image, there is a dislocation but the glenoid implant remains within the native glenoid.On the axillary image, there is a shoulder arthroplasty dislocation and the glenoid implant is displaced from the glenoid.Recent operative changes are seen in the soft tissues.Based on the x-ray review the humeral implant fit is maintained.The glenoid implant is loose and displaced as noted.There is malalignment secondary to the implant loosening, disassociation and dislocations as noted.However, 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 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: ANATOMICAL SHOULDER¿¢ REVERSE, SCREW SYSTEM, 4.5-18
• Common Device Name: PROSTHESIS, SHOULDER
• 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: 20663697
• Report Number: 0009613350-2024-00534
• Device Sequence Number: 8231216
• Product Code: HSD
• UDI-Device Identifier: 00889024482999
• UDI-Public: (01)00889024482999(17)290208(10)3198214
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K193099
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/20/2024

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: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 0104223018
• Device Lot Number: 3198214
• 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: 10/18/2024
• Supplement Date Received by Manufacturer: 12/13/2024
• Initial Report FDA Received Date: 11/12/2024
• Supplement Report FDA Received Date: 12/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/08/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown