MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH MRS SM FEM STEM 10 X 102MM PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number 6485-3-000

Device Problems Fracture (1260); Failure to Osseointegrate (1863)

Patient Problems Ambulation Difficulties (2544); Inadequate Osseointegration (2646)

Event Date 10/12/2020

Event Type  Injury  

Manufacturer Narrative

It was noted that the device is not available for evaluation. Should additional information become available, it will be provided in a supplemental report upon completion of the investigation. 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. Device not returned.

Event Description

It was reported by the sales rep that the surgeon informed of an issue of a broken gmrs stem on 26oct2020 (current stem diameter 10mm ref 6485-3-000, ln 187138a) and the need to revise to a thicker stem (11 or 13mm). Current stem was implanted on (b)(6) 2019 (primary surgery). Revision surgery is planned on (b)(6) 2020. Update: "surgeon mentioned implant likely have loosened and broken due to patient riding motorcycle and using her legs to stop the bike (excessive stress to implant) patient had broken implant in (b)(6) 2020 but was unable to come in due to covid, hence the delay to nov surgery. ".

• Brand Name: MRS SM FEM STEM 10 X 102MM
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-LIMERICK; raheen business park; limerick NA ; EI NA
• Manufacturer Contact: daniela davila ; 2555 davie road; centennial park, elstree; fort lauderdale, FL 33317 ; 9546280700
• MDR Report Key: 10854626
• MDR Text Key: 216845300
• Report Number: 0002249697-2020-02475
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: K040749
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 01/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: 6485-3-000
• Device Catalogue Number: 64853000
• Device Lot Number: 187138A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 12/15/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/08/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 11/17/2020 Patient Sequence Number: 1