MAUDE Adverse Event Report: STRYKER GMBH 6.5MM CENTER SCREW - 24M M; SHOULDER JOINT METAL/POLYMER SEMI-CONSTRAINED CEMENTED PROSTHESIS.

Catalog Number	5573-6524
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	02/27/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available it will be provided on a supplemental report.Device was disposed after removal.
Event or Problem Description
We were revising a reverse total shoulder.The baseplate with the glenosphere came out all together.There was no ingrowth on the baseplate.The patient had no infection.The surgeon had to covert him to a hemi arthroplasty as there was no bone left around the glenoid.
Additional Manufacturer Narrative
Available x-ray image and event description did not identify a product deficiency.The item did not contribute to the event.Thus, concomitant item.
Event or Problem Description
We were revising a reverse total shoulder.The baseplate with the glenosphere came out all together.There was no ingrowth on the baseplate.The patient had no infection.The surgeon had to covert him to a hemi arthoplasty as there was no bone left around the glenoid.

• Brand Name: 6.5MM CENTER SCREW - 24M M
• 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: 7923892
• Report Number: 0008031020-2018-00690
• Device Sequence Number: 19194863
• Product Code: KWS
• UDI-Device Identifier: 07613327098815
• UDI-Public: 07613327098815
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: K130895
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/05/2018

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: 5573-6524
• Device Lot Number: MNN661
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/10/2018
• Supplement Date Received by Manufacturer: 09/11/2018
• Initial Report FDA Received Date: 10/01/2018
• Supplement Report FDA Received Date: 10/05/2018
• 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: 83 YR