MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN FEMORAL STEM COMPONENT; UNKNOWN KNEE IMPLANT

Catalog Number	UNK_LIM
Medical Device Problem Codes	Break (1069); Fracture (1260); Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Injury (2348); Inadequate Osseointegration (2646)
Date of Event	08/28/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.
Event or Problem Description
It was reported that patient's right knee was revised due to aseptic loosening of the femur and tibia, as well as a broken femoral stem at the stem/ offset bolt interface.Rep reported the patient's entire knee was revised.
Additional Manufacturer Narrative
Non bone interfacing device reported in error.Updated information for unknown bone interfacing device (femoral stem) provided corrections to: d1, d2, d4, d6, g5, h4 and h6 codes an event regarding femoral and tibial loosening as well as a fracture of the femoral stem involving an unknown stem component was reported.The event was confirmed based on clinician review of the x-rays provided.Method & results: -device evaluation and results: not performed as the device was not returned for evaluation.-medical records received and evaluation: a review of the provided medical records by a clinical consultant stated the following comment: x-ray confirms fractured femoral stem; need revision operative report and examination of explanted components.-device history review: not performed as the lot id was not provided.-complaint history review: not performed as the lot id was not provided.Conclusions: review of the provided medical records by a clinical consultant stated the following comment: x-ray confirms fractured femoral stem.The exact cause of the event could not be determined because insufficient information was provided.Additional information, including revision operative report and examination of explanted components 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
It was reported that patient's right knee was revised due to aseptic loosening of the femur and tibia, as well as a broken femoral stem at the stem/ offset bolt interface.Rep reported the patient's entire knee was revised.

• Brand Name: UNKNOWN FEMORAL STEM COMPONENT
• Common Device Name: UNKNOWN KNEE IMPLANT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 7908433
• Report Number: 0002249697-2018-03037
• Device Sequence Number: 16564988
• Product Code: KRO
• UDI-Device Identifier: 07613327045208
• UDI-Public: 07613327045208
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K002552
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 1996
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/01/2018

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 Expiration Date: 02/28/2018
• Device Catalogue Number: UNK_LIM
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/28/2018
• Supplement Date Received by Manufacturer: 10/04/2018
• Initial Report FDA Received Date: 09/25/2018
• Supplement Report FDA Received Date: 11/01/2018
• 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: Hospitalization; Required Intervention
• Patient Age: 72 YR
• Patient Weight: 91