MAUDE Adverse Event Report: STRYKER GMBH GLENOSPHERE - 32MM DIA X 2MM THK CONCENTRIC; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	5573-C-3202
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	09/23/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Retained by hospital.
Event or Problem Description
Suspected glenoid loosening of reunion rsa implants leading to revision surgery.

• Brand Name: GLENOSPHERE - 32MM DIA X 2MM THK CONCENTRIC
• 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: 9212572
• Report Number: 0008031020-2019-01474
• Device Sequence Number: 410612
• Product Code: KWS
• UDI-Device Identifier: 07613327098877
• UDI-Public: 07613327098877
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K130895
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician Assistant
• Type of Report: Initial
• Report Date (Section B): 10/20/2019

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?: No
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 5573-C-3202
• Device Lot Number: J46W6K
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/23/2019
• Initial Report FDA Received Date: 10/20/2019
• 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