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

Model Number	6481-2-120
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	10/17/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was noted that the device is not available for evaluation.If additional information is received, 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 reported discrepancies.There have been no other events for the lot referenced.The following devices were also listed in this report: mrh knee fem m rgt; cat# 64811121; lot# stckp, mrhk tib ins 20mm md/lg m2/l2; cat# 64813320; lot# lcn141, ti dur reg fluted stem 16x80mm; cat# 64786630; lot# t2457, ti dur reg fluted stem 19x80mm; cat# 64786645; lot# t1172, mrhk fem distal blk 10mm m; cat# 64811220; lot# s8ddy, mrhk fem distal blk 10mm m; cat# 64811220; lot# s3yec, mrhk femoral bushing; cat# 64812110; lot# lco014, mrhk femoral bushing; cat# 64812110; lot# lcr448, mrhk bumper insert 3 degrees; cat# 64812133; lot# lcr280, mrhk tibial sleeve; cat# 64812140; lot# lcs352, mrh tibial b/plt keel med 2; cat# 64813112; lot# syf4d, it cannot be determined which, if any of these devices may have caused or contributed, to the patient's experience.
Event or Problem Description
Revision of mrh initially done in 2012.Surgeon outlined reason for revision as metalosis infection.The surgeon removed all mrh implants and implanted a competitor spacer.

• Brand Name: MRH AXLE
• Common Device Name: 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: brad curtis ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 15788327
• Report Number: 0002249697-2022-01617
• Device Sequence Number: 5613477
• Product Code: KRO
• UDI-Device Identifier: 07613327045253
• UDI-Public: 07613327045253
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K002552
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/14/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/26/2016
• Device Model Number: 6481-2-120
• Device Catalogue Number: 64812120
• Device Lot Number: CTD1038
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/17/2022
• Initial Report FDA Received Date: 11/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/27/2011
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 77 YR
• Patient Sex: Male