MAUDE Adverse Event Report: STRYKER GMBH 4.5MM PERIPHERAL SCREW - 24MM; SHOULDER JOINT METAL/POLYMER SEMI-CONSTRAINED CEMENTED PROSTHESIS.

Catalog Number	5572-4524
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	07/09/2018
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.Retained by hospital,.
Event or Problem Description
It was reported that patient's right shoulder was revised due to the glenosphere disengaging from baseplate.Surgeon suspected the glenosphere may have been malpositioned at time of implant.Additionally, patient reported had experienced a fall in the past year.
Additional Manufacturer Narrative
Investigation revealed the subject product to be a concomitant item.The device did not contribute to the reported event.
Event or Problem Description
It was reported that patient's right shoulder was revised due to the glenosphere disengaging from baseplate.Surgeon suspected the glenosphere may have been malpositioned at time of implant.Additionally, patient reported had experienced a fall in the past year.

• Brand Name: 4.5MM PERIPHERAL SCREW - 24MM
• Common Device Name: SHOULDER JOINT METAL/POLYMER SEMI-CONSTRAINED CEMENTED PROSTHESIS.
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 7732919
• Report Number: 0008031020-2018-00533
• Device Sequence Number: 1588436
• Product Code: KWS
• UDI-Device Identifier: 07613327098730
• UDI-Public: 07613327098730
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K130895
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/08/2018

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: 5572-4524
• Device Lot Number: 4944AP
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/09/2018
• Supplement Date Received by Manufacturer: 07/18/2018
• Initial Report FDA Received Date: 07/30/2018
• Supplement Report FDA Received Date: 08/08/2018
• 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: 72 YR