MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH KINEMAX S/STAB MOD STM TRIAL LN; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	6778-7-060
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/26/2019
Type of Reportable Event	Malfunction
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.Device remains implanted.
Event or Problem Description
During a routine mrh case trial stem was seen by intra op xray to be inside patients femoral canal.Attempts made to remove but unable to do so and trial implant was cemented inside femur.Update: "left side.Activity level: wheel chair bound, pre existing conditions right knee amputation".

• Brand Name: KINEMAX S/STAB MOD STM TRIAL LN
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 8818888
• Report Number: 0002249697-2019-02638
• Device Sequence Number: 327639
• Product Code: LXH
• UDI-Device Identifier: 07613327128703
• UDI-Public: 07613327128703
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 6778-7-060
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/26/2019
• Initial Report FDA Received Date: 07/23/2019
• 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: Other
• Patient Age: 38 YR