MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH SIDUS STEM-FREE SHOULDER, HUMERAL ANCHOR, UNCEMENTED, L; SHOULDER PROSTHESIS

Model Number	01.04555.130
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Unspecified Infection (1930); Osteolysis (2377)
Date of Event	09/06/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Medical devices: modular humeral head 30 mm head height 52 mm spherical head diameter; item# 00430005230; lot# 61194309; trabecular metaloc glenoid component 52 mm articular surface use with blue instruments & blue humeral head; item# 00432605200; lot# 63924825.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 the patient underwent a shoulder replacement surgery and approximately 4 years later a revision to a spacer was performed due to infection and loosening.Due diligence is in progress for this complaint; to date no additional information or product has been received.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.Visual examination of the provided pictures shows what appears to bone through-growth on the anchor fins, no further information can be gleaned from the photograph.Review of the device history records identified no deviations or anomalies during manufacturing.Device is used for treatment.Medical radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: a right shoulder arthroplasty is present.There is no fracture or dislocation.There is extensive osteolysis involving the humeral and glenoid implant fixation with suspected implant loosening but no implant displacement.The extensive osteolysis present could be related to infection, but this is not certain.Regardless of the cause, this degree of osteolysis would lead to loosening.The root cause of the reported issue is attributed to non-device related infection leading to loosening.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
No further event information available at the time of this report.

• Brand Name: SIDUS STEM-FREE SHOULDER, HUMERAL ANCHOR, UNCEMENTED, L
• Common Device Name: SHOULDER PROSTHESIS
• 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: 15637076
• Report Number: 0009613350-2022-00550
• Device Sequence Number: 14923227
• Product Code: PKC
• UDI-Device Identifier: 00889024397187
• UDI-Public: (01)00889024397187(17)280131(10)2922197
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: N/A
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/13/2022

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 Model Number: 01.04555.130
• Device Catalogue Number: 0104555130
• Device Lot Number: 2922197
• 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: 09/06/2022
• Supplement Date Received by Manufacturer: 10/24/2022; 12/12/2022
• Initial Report FDA Received Date: 10/20/2022
• Supplement Report FDA Received Date: 11/17/2022; 12/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/29/2018
• 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
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 75 YR
• Patient Sex: Male