MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 80MM SMALL ULNA COMPONENT, RIGHT; PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED

Catalog Number	5005-U-080R
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	07/18/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
Patient specific solutions reported receiving an implant request for a custom/ customized ulnar for a patient with a broken implant per surgeon request.Revision has not taken place.
Additional Manufacturer Narrative
Date of implant.An event regarding crack/fracture involving a custom ulna was reported.The event was not confirmed.Method & results: product evaluation and results: not performed as the device was not returned for evaluation.Clinician review: not performed as no medical records were available for review.Device history review: not performed as the lot code was not provided.Complaint history review: not performed as the lot code was not provided.Conclusions: it was reported that the patient had a broken implant.The event could not be confirmed nor the root cause be determined as insufficient information was received.Further information such as patient demographics, revision operative reports, serial x-rays, lab and progress notes, and examination of explanted components are need to further evaluate.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
Patient specific solutions reported receiving an implant request for a custom/ customized ulnar for a patient with a broken implant per surgeon request.Revision has not taken place.

• Brand Name: 80MM SMALL ULNA COMPONENT, RIGHT
• Common Device Name: PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 7785514
• Report Number: 0002249697-2018-02541
• Device Sequence Number: 11275026
• Product Code: HSD
• UDI-Device Identifier: 07613327138450
• UDI-Public: 07613327138450
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K062845
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/12/2018

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: Health Professional
• Device Catalogue Number: 5005-U-080R
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/18/2018
• Supplement Date Received by Manufacturer: 10/15/2018
• Initial Report FDA Received Date: 08/15/2018
• Supplement Report FDA Received Date: 11/12/2018
• 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: Other
• Patient Age: 19 YR
• Patient Weight: 91