MAUDE Adverse Event Report: STRYKER GMBH 4.5MM PERIPHERAL SCREW - 28MM; SHOULDER JOINT METAL/POLYMER SEMI-CONSTRAINED CEMENTED PROSTHESIS.

Catalog Number	5572-4528
Health Effect - Clinical Codes	Fall (1848); Pain (1994)
Date of Event	08/08/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
It was reported that patient's right shoulder was revised after patient suffered several falls and complained of pain.The glenoid baseplate was found to have loosened.Surgeon decided to use bone allograft in the glenoid and a humeral head on the existing stem.
Additional Manufacturer Narrative
Investigation revealed the subject product to be a concomitant item.The device did not contribute to the reported event.If any additional information is provided indicating otherwise the record will be reopened and the investigation will be reworked.
Event or Problem Description
It was reported that patient's right shoulder was revised after patient suffered several falls and complained of pain.The glenoid baseplate was found to have loosened.Surgeon decided to use bone allograft in the glenoid and a humeral head on the existing stem.

• Brand Name: 4.5MM PERIPHERAL SCREW - 28MM
• 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: 7848591
• Report Number: 0008031020-2018-00584
• Device Sequence Number: 1678624
• Product Code: KWS
• UDI-Device Identifier: 07613327098747
• UDI-Public: 07613327098747
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 09/25/2018

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: 5572-4528
• Device Lot Number: 4J1788
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/08/2018
• Supplement Date Received by Manufacturer: 08/30/2018
• Initial Report FDA Received Date: 09/05/2018
• Supplement Report FDA Received Date: 09/25/2018
• 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: 70 YR
• Patient Weight: 118