MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH KMAX STEM EXTNR(S,M,L,XL)155MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/META

Catalog Number	64768270
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Injury (2348)
Date of Event	03/14/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was noted that the device is not available for evaluation.A review of the device history records indicate that devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
Revision of an mrh femur due to a broken 155mm cemented stem.The mrh tibia did not require revision, but the femur was revised to a gmrs femoral component.
Event or Problem Description
Revision of an mrh femur due to a broken 155mm cemented stem.The mrh tibia did not require revision, but the femur was revised to a gmrs femoral component.
Additional Manufacturer Narrative
An event regarding crack/fracture of a kinemax stem was reported.The event was confirmed through review of the provided x-rays by a clinical consultant.Method & results: device evaluation and results: not performed as product was not returned.-medical records received and evaluation: a review of the provided medical records by a clinical consultant stated the following comment: "rejected for medical review on (b)(6) 2019: provided x-ray confirms stem fracture.Need further information such as, operative reports, office/clinical reports, serial x-rays, and examination of the explanted components".Device history review: the device was manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other events for the lot referenced.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.

• Brand Name: KMAX STEM EXTNR(S,M,L,XL)155MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/META
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 8503553
• Report Number: 0002249697-2019-01576
• Device Sequence Number: 10812660
• Product Code: JWH
• UDI-Device Identifier: 07613327045369
• UDI-Public: 07613327045369
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K904208
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/30/2019

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: 03/31/2018
• Device Catalogue Number: 64768270
• Device Lot Number: CTD2239
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/14/2019
• Supplement Date Received by Manufacturer: 05/03/2019
• Initial Report FDA Received Date: 04/11/2019
• Supplement Report FDA Received Date: 05/30/2019
• 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: 66 YR
• Patient Weight: 140