MAUDE Adverse Event Report: ZIMMER GMBH SIDUS® STEM-FREE SHOULDER, HUMERAL ANCHOR; PROSTHESIS, EXTREMITY

Model Number	N/A
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Pain (1994); Osteolysis (2377); Subluxation (4525)
Date of Event	01/29/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10.3 peg mono glen sz 2 item# sagl2022 lot# 64975073 unk palacos cement.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: 0009613350-2024-00080.
Event or Problem Description
It was reported that the patient underwent an initial left primary anatomical total shoulder replacement approximately 2 years ago.Subsequently, approximately one month ago the patient was converted to a left reverse total shoulder replacement due to subscapularis failure and subluxation of the humeral head; humeral component was found grossly loose.Glenoid component and humeral head were explanted.Diligence is complete and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
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 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.The root cause for the reported event of subscapularis failure is determined to be unrelated to the device.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.
Event or Problem Description
It was reported that the patient underwent an initial left primary anatomical total shoulder.Subsequently, approximately two years post implantation the patient was converted to a left reverse total shoulder replacement due to subscapularis failure and subluxation of the humeral head; humeral component was found grossly loose.Glenoid component and humeral head were explanted.Diligence is complete and additional information on the reported event is unavailable at this time.

• Brand Name: SIDUS® STEM-FREE SHOULDER, HUMERAL ANCHOR
• 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: 18828319
• Report Number: 0009613350-2024-00081
• Device Sequence Number: 7786618
• Product Code: HSD
• UDI-Device Identifier: 00889024397170
• UDI-Public: (01)00889024397170(17)311022(10)3086029
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K171858
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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
• Report Date (Section B): 03/21/2024

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 Model Number: N/A
• Device Catalogue Number: 0104555120
• Device Lot Number: 3086029
• 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: 02/07/2024
• Supplement Date Received by Manufacturer: 03/06/2024
• Initial Report FDA Received Date: 03/04/2024
• Supplement Report FDA Received Date: 03/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/22/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Congenital Anomaly; Hospitalization
• Patient Age: 66 YR
• Patient Sex: Female
• Patient Weight: 73 KG