MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH MRH KNEE FEM S LFT; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number 6481-1-110

Device Problems Break (1069); Fracture (1260)

Patient Problem Ambulation Difficulties (2544)

Event Date 07/22/2021

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.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.Device not returned.

Event Description

The following was reported: femoral implant rupture at the junction between keel and femoral shield.Revision surgery required.

Manufacturer Narrative

Reported event: an event regarding crack/fracture involving a mrh femoral component was reported.The event was confirmed via evaluation of the returned device and review of the medical records by a clinical consultant.Method & results: product evaluation and results: visual inspection: visual inspection of the returned devices was performed as part of the material analysis.On visual examination, the fracture was observed through the boss of the mrh knee, approximately 12 mm from the proximal tip.Material analysis: a material analysis was performed and concluded the following: "review of mrh knee fem xs lft, catalogue # 6481-1-110, lot code s3kdb confirmed a fracture through the boss.Characterisation using stereo microscopy and scanning electron microscopy confirmed the fracture propagated in fatigue." clinician review: a review of the provided medical information by a clinical consultant indicated: "the patients 2013 surgery was undertaken for chronic instability of a previously revised total stabilized knee.The patient apparently did well until the stem of the hinged femoral component fractured 8 years hence.In the post operative note there is commentary that the patient suffered a fall in 2020.It is unclear if this had any bearing on the stem fracture.The preoperative x-rays demonstrate a transverse fracture of the femoral stem at the level of the boss/stem interface.Following review of this documentation failure of the mrh femoral stem via fracture is confirmed as is the subsequent revision.The limited documentation precludes determination of a root cause for this failure." -product history review: review of the device history records indicate the devices were manufactured and accepted into final stock, with no relevant reported discrepancies.-complaint history review: there have been no other similar events for the lot referenced.Conclusions: it was reported that the patient was revised due to fracture of the mrh femoral component.The device was returned for evaluation and a material analysis was performed.The material analysis concluded the following: "review of mrh knee fem xs lft, catalogue # 6481-1-110, lot code s3kdb confirmed a fracture through the boss.Characterisation using stereo microscopy and scanning electron microscopy confirmed the fracture propagated in fatigue." a review of the medical records by a clinical consultant also confirmed the event and indicated that not enough information was provided to determine a root cause, although the reported patient fall may have contributed to the event.No further investigation for this event is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

Event Description

The following was reported: femoral implant rupture at the junction between keel and femoral shield.Revision surgery required.

• Brand Name: MRH KNEE FEM S LFT
• 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: anna ryan ; raheen business park; limerick NA ; EI NA ; 61498200
• MDR Report Key: 12506202
• MDR Text Key: 272464698
• Report Number: 0002249697-2021-01595
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: 07613327045130
• UDI-Public: 07613327045130
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K002552
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/10/2023

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
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2016
• Device Model Number: 6481-1-110
• Device Catalogue Number: 64811110
• Device Lot Number: S3KDB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/27/2021
• Initial Date FDA Received: 09/21/2021
• Supplement Dates Manufacturer Received: 12/23/2022
• Supplement Dates FDA Received: 01/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/07/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 71 YR
• Patient Weight: 79 KG