MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH MRHK TIB INS 20MM MD/LG M2/L2; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number 64813320

Device Problems Microbial Contamination of Device (2303); Insufficient Information (3190)

Patient Problems Unspecified Infection (1930); Injury (2348)

Event Date 10/02/2019

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 of the investigation.

Event Description

Patient had a revision mrh procedure done in march of this year and it became infected, patient had a history of prior infections.

Manufacturer Narrative

Correction: update to catalog and lot numbers, update to implant date.An event regarding infection involving an mrh insert was reported.The event was not confirmed.Method & results: -product evaluation and results: not performed as product was not returned -medical records received and evaluation: "cannot confirm event, need additional information; primary and revision operative reports, clinical and past medical history, additional serial dated x-rays and examination of explanted components." -product history review: all 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 reported lot.There have been no other similar events for the reported sterile lot.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Additional information, including operative reports, pathology report, 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.The following devices were also listed in this report: sterile fluted headless 1/8" pin 3.5" long; cat# 7650-2038a; lot# sc23163h6 triathlon asymmetric x3 patella; cat# 5551-g-401; lot# ert7 sterile fluted headless 1/8" pin 3.5" long ; cat# 7650-2038a; lot# sc25430hh mrh tib rot comp xs-xl; cat# 64812100; lot# 144649 mrh knee fem xl rht; cat# 64811141; lot# a3e6n mrhk tibial sleeve; cat# 64812140; lot# lhn774 ti dur reg fluted stem21x155mm; cat# 64786740; lot# t3743 mrh tibial b/plt keel lrg 2; cat# 64813113; lot# dnj6t mrhk femoral bushing; cat# 64812110; lot# lhr617 ti dur reg fluted stem 17x80mm; cat# 64786635; lot# 0051995 mrhk femoral bushing; cat# 64812110; lot# lhr888 mrhk bumper insert - neutral; cat# 64812130; lot# lhq526 mrh axle; cat# 64812120; lot# ctd32320 it cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.

Event Description

Patient had a revision mrh procedure done in march of this year and it became infected, patient had a history of prior infections.

• Brand Name: MRHK TIB INS 20MM MD/LG M2/L2
• 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: 9247358
• MDR Text Key: 165618225
• Report Number: 0002249697-2019-03633
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• PMA/PMN Number: K994207
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 01/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2019
• Device Catalogue Number: 64813320
• Device Lot Number: LDT184
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 59 YR