MAUDE Adverse Event Report: ZIMMER GMBH SIDUS® STEM-FREE SHOULDER, HUMERAL HEAD, 42-15; PROSTHESIS, EXTREMITY

Model Number N/A

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Pain (1994); Osteolysis (2377); Subluxation (4525)

Event Date 01/29/2024

Event Type  Injury  

Event 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.

Manufacturer Narrative

(b)(4).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: 0009613350-2024-00081.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected: b4, g3, g6, h2, h6, h10.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.Medical records (case report form (crf) as well as surgical notes etc.) were provided and reviewed by a healthcare professional with the following assessment: no intraoperative complications noted during primary implantation.No defects noted with rotator cuff and bone quality normal for both glenoid and humerus.Excellent stability, no instability, and no impingement.-severe problems with activies of daily living (adl's ) and severe pain or discomfort noted 6 months post-op.No abnormal findings on xray.Ct scan approximately 18 months post-implantation noted subscapularis failure and subluxation of the humerus head.Lysis was also noted around the humeral component.Lysis likely represents either a rotator cuff tear with secondary mechanical lysis or possible infection, patient sent for labs and aspiration.Clinic visit 3 days later identified clunking sensation with internal/external rotation.Xray show increase lysis but also anterior subluxation of the humeral head relative to the glenoid.Subsequent clinic visit identified aspiration no growth after 9 days, labs normal.Ct showed loosening of the humeral component with subscapularis failure.Patient revised to rtsa approximately 3 weeks after the issue was discovered.Subscapularis was found to be failed.Humeral component was found grossly loose, it was removed easily by hand.Glenoid component was fixed in excellent position, osteotome used to remove with minimal bone loss.No intraoperative complications reported.New implants were intact and well fixed.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.Multiple mdr reports were filed for this event, please see associated reports: 0009613350-2024-00081-1.

Event Description

Diligence is complete and additional information on the reported event is unavailable at this time.

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.Multiple mdr reports were filed for this event, please see associated reports: 0009613350-2024-00081-1.

Event 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 HEAD, 42-15
• Type of Device: 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: 18828316
• MDR Text Key: 336803075
• Report Number: 0009613350-2024-00080
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 00889024415928
• UDI-Public: (01)00889024415928(17)311020(10)3088890
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K171858
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 0104555420
• Device Lot Number: 3088890
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/28/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/20/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 66 YR
• Patient Sex: Female
• Patient Weight: 73 KG