MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SHOULDER - OFF SET HUMERAL HEAD 50MMX18MM; PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED

Catalog Number	5352-5018
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/04/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
Cuff failure of hemi.Revision of stryker solar tsa hemi to rsa.
Additional Manufacturer Narrative
An event regarding patient factors involving a solar head was reported.The event was confirmed via clinician review of the provided medical records.Method & results: -product evaluation and results: the device was not retuned for inspection; however, photographs were provided for review.The photographs show a recently explanted solar head.There is nothing remarkable to note.-clinician review: a review of the provided medical records by a clinical consultant indicated: "i can confirm that the patient had a primary right shoulder hemi arthroplasty that failed due to failure of the rotator cuff since i was able to see the x-rays showing the implant that were consistent with rotator cuff arthropathy.Root cause analysis: the root cause of this event i believe can be determined.The implant actually had excellent longevity having remained in place for over 25 years.The reason for the revision was failure of the rotator cuff with the shoulder losing the stabilization necessary to keep it within the glenoid.Patient factors play a role in that the rotator cuff obviously was torn completely which could have been due to trauma or a degenerative process." -product history review: review of the device history records could not be performed as the dhr could not be located.-complaint history review: there have been no other similar events for the lot referenced.Conclusions: it was reported that the patient will be revised due to failure of the rotator cuff.A review of the provided medical records by a clinical consultant indicated: "i can confirm that the patient had a primary right shoulder hemi arthroplasty that failed due to failure of the rotator cuff since i was able to see the x-rays showing the implant that were consistent with rotator cuff arthropathy.Root cause analysis: the root cause of this event i believe can be determined.The implant actually had excellent longevity having remained in place for over 25 years.The reason for the revision was failure of the rotator cuff with the shoulder losing the stabilization necessary to keep it within the glenoid.Patient factors play a role in that the rotator cuff obviously was torn completely which could have been due to trauma or a degenerative process." the device was not retuned for inspection; however, photographs were provided for review.The photographs show a recently explanted solar head.There is nothing remarkable to note.No further investigation for this event is possible at this time.If devices and/or additional information become available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
Cuff failure of hemi.Revision of stryker solar tsa hemi to rsa.

• Brand Name: SHOULDER - OFF SET HUMERAL HEAD 50MMX18MM
• Common Device Name: PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: brad curtis ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 20348157
• Report Number: 0002249697-2024-01343
• Device Sequence Number: 7842403
• Product Code: HSD
• UDI-Device Identifier: 07613327138146
• UDI-Public: 07613327138146
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K001419
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 1999
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/12/2024

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 5352-5018
• Device Lot Number: 27076901
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/04/2024
• Supplement Date Received by Manufacturer: 10/23/2024
• Initial Report FDA Received Date: 10/01/2024
• Supplement Report FDA Received Date: 11/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Hospitalization; Required Intervention
• Patient Age: 66 YR
• Patient Sex: Unknown
• Patient Weight: 107 KG