MAUDE Adverse Event Report: STRYKER GMBH HUMERAL CUP - 36MM DIA X 10MM THK; SHOULDER JOINT METAL/POLYMER SEMI-CONSTRAINED CEMENTED PROSTHESIS.

Catalog Number	5570-3610
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/05/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available it will be provided on a supplemental report.Device is implanted.
Event or Problem Description
There were white flakes on the implant when it was removed from the packaging.Physician removed the white flakes and used the implant.
Event or Problem Description
There were white flakes on the implant when it was removed from the packaging.Physician removed the white flakes and used the implant.
Additional Manufacturer Narrative
The reported event that humeral cup - 36mm dia x 10mm thk was alleged of 'packaging: residue inside sterile blister or pouch' could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.Indeed, without the product returned or at least a picture of the event, it is impossible to determine the root cause.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 labeling 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.

• Brand Name: HUMERAL CUP - 36MM DIA X 10MM THK
• 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: 8122214
• Report Number: 0008031020-2018-01021
• Device Sequence Number: 1569125
• Product Code: KWS
• UDI-Device Identifier: 07613327098372
• UDI-Public: 07613327098372
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K130895
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2019
• Device Catalogue Number: 5570-3610
• Device Lot Number: MNLA7A
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/05/2018
• Supplement Date Received by Manufacturer: 01/17/2019
• Initial Report FDA Received Date: 12/01/2018
• Supplement Report FDA Received Date: 02/13/2019
• 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: Other
• Patient Age: 82 YR