MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH MRH TIBIAL B/PLT KEEL SML 1; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	64813110
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Unspecified Infection (1930); Pain (1994); Injury (2348); Inadequate Osseointegration (2646)
Date of Event	03/01/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The following devices were also listed in this report: mrh knee fem m lft; cat# 64811120; lot# ane8m, mrh axle; cat# 64812120; lot# ctd10657, mrh tib rot comp xs-xl; cat# 64812100; lot# 089720, mrhk fem distal blk 10mm m; cat# 64811220; lot# ane9a, mrhk tib ins 20mm xs/s s1/s2; cat# 64813220; lot# lds029, mrhk tibial sleeve; cat# 64812140; lot# lex913, triathlon sym cone aug sz c; cat# 5549-a-130; lot# a915, triathlon fem cone aug sz 5l; cat# 5549-a-351; lot# a8j5, tri press-fit stem 14mm x 100mm; cat# 5565-s-014; lot# 0037827b, tri press-fit stem 14x150mm; cat# 5566-s-014; lot# 00408701, mrhk femoral bushing; cat# 64812110; lot# unknown, mrhk bumper insert - neutral; cat# 64812130; lot# unknown.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.Review of the device history records indicate the devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other similar events for the sterile lot referenced.It was noted that the device is not available for evaluation.Additional information has been requested and if received, will be provided in the supplemental report upon completion of the investigation.
Event or Problem Description
Patient stated that on or about (b)(6) 2016, she started experiencing pain again.Patient went to a doctor and it was found that the tibia was loose again and she had an infection.On (b)(6) 2016 she had a revision.

• Brand Name: MRH TIBIAL B/PLT KEEL SML 1
• Common Device Name: PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 6855931
• Report Number: 0002249697-2017-02723
• Device Sequence Number: 899339
• Product Code: KRO
• UDI-Device Identifier: 07613327045307
• UDI-Public: 07613327045307
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K002552
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/11/2017

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: 04/19/2021
• Device Catalogue Number: 64813110
• Device Lot Number: ARC2J
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/14/2017
• Initial Report FDA Received Date: 09/11/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 67 YR
• Patient Weight: 91