MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SM, LT ULNA COMPONENT; PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED

Catalog Number	5005-102L
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Osseointegration Problem (3003)
Health Effect - Clinical Codes	Injury (2348); Inadequate Osseointegration (2646)
Date of Event	12/13/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the device history records "indicate" devices were manufactured and accepted into final stock on with no relevant reported discrepancies.Based on the device identification the complaint databases were reviewed for similar reported events regarding "aeseptic" loosening.There have been no other similar events for the reported lot.It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
Revision of ulnar component for aseptic loosening.
Additional Manufacturer Narrative
Initial reporter type.Additional information: g5 510k provided.An event regarding loosening involving a solar ulna device was reported.The event was not confirmed.Method & results: device evaluation and results: not performed as product was not returned medical records received and evaluation: no medical records were received for review with a clinical consultant device history review: all devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there have been no other similar events for the reported lot.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Additional information including operative reports, progress notes, x-rays and return of the device are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.
Event or Problem Description
Revision of ulnar component for aseptic loosening.

• Brand Name: SM, LT ULNA COMPONENT
• Common Device Name: PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 8232520
• Report Number: 0002249697-2019-00133
• Device Sequence Number: 1745763
• Product Code: JDC
• UDI-Device Identifier: 07613327137590
• UDI-Public: 07613327137590
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K980502
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2019

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: Health Professional
• Device Expiration Date: 01/31/2019
• Device Catalogue Number: 5005-102L
• Device Lot Number: MNAHM9
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/13/2018
• Supplement Date Received by Manufacturer: 01/22/2019
• Initial Report FDA Received Date: 01/09/2019
• Supplement Report FDA Received Date: 02/19/2019
• 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: Hospitalization; Required Intervention
• Patient Age: 81 YR
• Patient Weight: 84