MAUDE Adverse Event Report: STRYKER GMBH HUMERAL CUP - 36MM DIA X 4MM THK; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	5570-3604
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	03/13/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient underwent a revision surgery.In an update, it was mentioned that the patient was unstable, leading the surgeon to change the implants to address the instability issues.Reunion implants were used to upsize the implants and wash out the patient during the surgery.
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided on a supplemental report.The device was discarded by the hospital.
Additional Manufacturer Narrative
A device inspection was not possible since the affected device was not returned.The provided picture was reviewed: it corresponds to the implants sheet of the revision surgery, thus no additional details on the initial implants and/or the reported event was found.With the available evidence, no further evaluation is possible and the event cannot be confirmed.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.A review of the device history was not possible because the correct lot number was not communicated.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.Indications of material, manufacturing, or design related problems were unable to be identified as the correct lot number was not communicated.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
The patient underwent a revision surgery.In an update, it was mentioned that the patient was unstable, leading the surgeon to change the implants to address the instability issues.Reunion implants were used to upsize the implants and wash out the patient during the surgery.

• Brand Name: HUMERAL CUP - 36MM DIA X 4MM THK
• Common Device Name: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 19073995
• Report Number: 0008031020-2024-00157
• Device Sequence Number: 12476088
• Product Code: KWS
• UDI-Device Identifier: 07613327098365
• UDI-Public: 07613327098365
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K202289
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2024

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: Lay User/Patient
• Device Catalogue Number: 5570-3604
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/13/2024
• Supplement Date Received by Manufacturer: 06/04/2024
• Initial Report FDA Received Date: 04/09/2024
• Supplement Report FDA Received Date: 06/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Age: 48 YR
• Patient Sex: Male
• Patient Race: White