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

Catalog Number	5570-3604
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Joint Dislocation (2374)
Date of Event	03/14/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device was not returned.If additional information becomes available, it will be provided in a supplemental report.Sent to pathology per or protocol.
Event or Problem Description
Surgeon reported that left reverse shoulder replacement due to a fracture has subluxed and dislocated.Ct scan showed large amount of fluid in the joint.Surgeon decided to revise the shoulder, evacuate and the fluid.He increased the tension with increased gleniosphere offset and thicker cup and liner.The shoulder appeared stable and the surgery was performed without incident.
Additional Manufacturer Narrative
The reported event could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.More detailed information about the complaint event such as pre-operative and post operative x-rays of the primary surgery must be available in order to determine the root cause of the complaint event.However, based on the complaint history, some possible root causes can be, but are not limited to: a user related issue such as a mistake during the implantation of the prosthesis.The patient's reaction to the device.Indeed, the ifu clearly lists pain and cysts as potential adverse effects.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
Surgeon reported that left reverse shoulder replacement due to a fracture has subluxed and dislocated.Ct scan showed large amount of fluid in the joint.Surgeon decided to revise the shoulder, evacuate and the fluid.He increased the tension with increased gleniosphere offset and thicker cup and liner.The shoulder appeared stable and the surgery was performed without incident.

• 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 ; CH 2545
• MDR Report Key: 8466013
• Report Number: 0008031020-2019-00340
• Device Sequence Number: 14144708
• 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: K130895
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/14/2019

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 Expiration Date: 09/30/2023
• Device Catalogue Number: 5570-3604
• Device Lot Number: 203LTL
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/14/2019
• Supplement Date Received by Manufacturer: 04/23/2019
• Initial Report FDA Received Date: 03/29/2019
• Supplement Report FDA Received Date: 05/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR
• Patient Weight: 95