MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH MRHK BUMPER INSERT - NEUTRAL PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number 6481-2-130

Device Problems Degraded (1153); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pain (1994)

Event Date 11/20/2020

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. Catalog numbers and lot codes of other devices listed in this report: 64812140, mrhk tibial sleeve, lot lcl758. 64952105, gmrs small femoral bushing, lot lcw343. 64952105, gmrs small femoral bushing, lot lcn680. 64813210, mrhk tib ins 10mm xs/s s1/s2, lot lcs554. 64952115, gmrs small axle, lot ctd777. 64812100, mrh tib rot comp xs-xl, lot 023234. It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.

Event Description

As reported: "patient had pain. X-rays showed potential damage to bumper and bushings. Surgeon performed poly swap to exchange the sleeve, insert, rotating component, two bushings, axle and bumper. " right side. Spoke to rep, who provided a picture of the explants and x-rays. Rep confirmed that no further information will be released by the hospital or surgeon.

• Brand Name: MRHK BUMPER INSERT - NEUTRAL
• 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: diana rogers ; 210 centennial avenue; centennial park, elstree; borehamwood WD6 3-SJ ; UK WD6 3SJ ; 2082386500
• MDR Report Key: 10987632
• MDR Text Key: 220902954
• Report Number: 0002249697-2020-02636
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K002552
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 01/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 08/31/2016
• Device Model Number: 6481-2-130
• Device Catalogue Number: 64812130
• Device Lot Number: LCO137
• 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: 01/07/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/24/2011
• 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: 12/10/2020 Patient Sequence Number: 1