MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH MRH XS/S/M LONG XOVER; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number 64812103

Device Problem Osseointegration Problem (3003)

Patient Problems Unspecified Infection (1930); Injury (2348); Inadequate Osseointegration (2646)

Event Date 04/05/2019

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.

Event Description

Sales rep in malaysia reported booking for revision surgery for gmrs distal femur possible on date (b)(6) 2019, implant loosening due to bone infection.

Manufacturer Narrative

Additional information: update to event description, implant, and explant dates.An event regarding infection and loosening involving an unknown femoral component was reported.The event was not confirmed.Method & results: product evaluation and results: not performed as no product was returned for evaluation.Clinician review: not performed as no medical records were received for review with a clinical consultant.Product history review: not performed as no lot information was provided.Complaint history review: not performed as no lot information was provided.Conclusions: the event itself could not be confirmed and exact cause of the event could not be determined because insufficient information was provided.Further information such as device identification and return, pre and post operative x-rays, operative reports, pathology reports including the strain of infection identified as well as patient history and follow up notes are required to complete the investigation for determining a root cause.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

Event Description

Update: revision surgery took place on (b)(6) 2019 due to infection and loosening because of patient disease, not because of implant failure.No further information available due to hospital confidentiality.Sales rep in malaysia reported booking for revision surgery for gmrs distal femur in my area possible on date (b)(6) 2019, implant loosening due to bone infection.Detailed information on the product, patient etc will only be available after the revision surgery on (b)(6) 2019.

Event Description

Update: revision surgery took place on (b)(6) 2019 due to infection and loosening because of patient disease, not because of implant failure.No further information available due to hospital confidentiality.Sales rep in malaysia reported booking for revision surgery for gmrs distal femur in my area possible on date (b)(6) 2019, implant loosening due to bone infection.Detailed information on the product, patient etc will only be available after the revision surgery on (b)(6) 2019.

Manufacturer Narrative

The following devices were also listed in this report: gmrs dist fem comp sml l 65mm; cat# 64952010; lot#ap46k.Gmrs extension piece 40mm; cat#64956040 ay43f.Mrs 11mm x 127mm femoral stem; cat#64853011; lot#146386b.Gmrs small femoral bushing; cat#64952105; lot#lfb654.Gmrs small femoral bushing; cat#64952105; lot#lfb655.Gmrs small axle; cat#64952115; lot#ctd2046.Mrhk tibial sleeve; cat#64812140; lot#lex909.Mrhk bumper insert ¿ neutral; cat#64812130; lot#lfc243.Mrh tib rot comp xs-xl; cat#64812100; lot#88768.Simplex abc ce mark 1 pck; cat#61969001; lot#bfx026.Simplex abc ce mark 1 pck; cat#61969001; lot#bdx016.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.An event regarding infection involving a mrh tibial component was reported.The event was not confirmed.Method & results: -product evaluation and results: not performed as no product was returned for evaluation.-clinician review: not performed as no medical records were received for review with a clinical consultant.-product history review: indicated all devices were manufactured and accepted into final stock with no reported discrepancies.-complaint history review: there have been no other similar events for the lot or sterile lot referenced.Conclusions: the event itself could not be confirmed and exact cause of the event could not be determined because insufficient information was provided.Further information such as device return, pre and post operative x-rays, operative reports, pathology reports including the strain of infection identified as well as patient history and follow up notes are required to complete the investigation for determining a root cause.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: MRH XS/S/M LONG XOVER
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 8575223
• MDR Text Key: 143884306
• Report Number: 0002249697-2019-01844
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• PMA/PMN Number: K002552
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup,Followup
• Report Date: 09/24/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2020
• Device Catalogue Number: 64812103
• Device Lot Number: 068813D
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/05/2019
• Initial Date FDA Received: 05/02/2019
• Supplement Dates Manufacturer Received: 05/30/2019; 08/27/2019
• Supplement Dates FDA Received: 06/25/2019; 09/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention