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

Catalog Number UNK_LIM

Device Problems Break (1069); Fracture (1260); Loss of Osseointegration (2408)

Patient Problems Injury (2348); Inadequate Osseointegration (2646)

Event Date 08/28/2018

Event Type  Injury  

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 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.

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 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
• Type of Device: UNKNOWN KNEE IMPLANT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 7908433
• MDR Text Key: 121704423
• Report Number: 0002249697-2018-03037
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: 07613327045208
• UDI-Public: 07613327045208
• Combination Product (y/n): N
• PMA/PMN Number: K002552
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 11/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2018
• Device Catalogue Number: UNK_LIM
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/04/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 72 YR
• Patient Weight: 91