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	Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	06/13/2018
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
In this revision of a reunion reverse shoulder, the baseplate had pulled out of glenoid.All screws peripheral screws had loosened with one escaping through the back of the base plate and floating free under clavicle.Rep reported that surgeon was unable to re-implant new baseplate due to bone loss, and therefore patient was converted to a hemi arthroplasty.
Event or Problem Description
In this revision of a reunion reverse shoulder, the baseplate had pulled out of glenoid.All screws peripheral screws had loosened with one escaping through the back of the base plate and floating free under clavicle.Rep reported that surgeon was unable to re-implant new baseplate due to bone loss, and therefore patient was converted to a hemi arthroplasty.
Additional Manufacturer Narrative
Concomitant medical products and device evaluated by mfr the reported event that 6.5mm center screw - 24m m was alleged of 'implant - loose' 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.Further information such as medical records, x-rays, surgery reports or progress notes will not be released from the hospital.Thus, a medical statement was not possible.A more precise evaluation was not possible.If the device is returned or if any additional information is provided, the investigation will be reassessed.H3 other text : device was not returned.

• 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: 7675599
• Report Number: 0008031020-2018-00490
• Device Sequence Number: 1384420
• Product Code: KWS
• UDI-Device Identifier: 07613327098815
• UDI-Public: 07613327098815
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2018

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: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/13/2018
• Supplement Date Received by Manufacturer: 08/14/2018
• Initial Report FDA Received Date: 07/10/2018
• Supplement Report FDA Received Date: 09/11/2018
• 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: 81 YR
• Patient Weight: 88