MAUDE Adverse Event Report: STRYKER GMBH GLENOSPHERE - 36MM DIA X 2MM THK CONCENTRIC; SHOULDER JOINT METAL/POLYMER SEMI-CONSTRAINED CEMENTED PROSTHESIS.

Catalog Number	5573-C-3602
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	09/21/2018
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 disposiiton is unknown.
Event or Problem Description
It was reported that patient's left reverse shoulder was revised due to a loose glenosphere.No trauma was reported.Surgeon reported suspicion that the glenosphere may not have been fully seated at implantation.
Event or Problem Description
It was reported that patient's left reverse shoulder was revised due to a loose glenosphere.No trauma was reported.Surgeon reported suspicion that the glenosphere may not have been fully seated at implantation.
Additional Manufacturer Narrative
The reported event alleged a 5573-c-3602 ¿ glenosphere had become loose was not confirmed since neither medical records nor the item itself was available.However, the surgeon performing the revisiosn suspected the glenosphere may not have been fully seated at the implantation.Additionally, it could not be determined if the baseplate had been seated appropriately.A miss-placed component would be regarded as user related.However, a real root cause could not be determined.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 labelling 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.With available information a product deficiency was not verified.

• Brand Name: GLENOSPHERE - 36MM DIA X 2MM THK CONCENTRIC
• 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: 7986133
• Report Number: 0008031020-2018-00880
• Device Sequence Number: 13801632
• Product Code: KWS
• UDI-Device Identifier: 07613327098884
• UDI-Public: 07613327098884
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/28/2018

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 Expiration Date: 10/31/2022
• Device Catalogue Number: 5573-C-3602
• Device Lot Number: 581ATJ
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/21/2018
• Supplement Date Received by Manufacturer: 12/04/2018
• Initial Report FDA Received Date: 10/19/2018
• Supplement Report FDA Received Date: 12/28/2018
• 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: 57 YR
• Patient Weight: 84