MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH MRHK TIB INS 10MM M/L M2/L2; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number	6481-3-310
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	07/02/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The following devices were also listed in this report: 64811121;mrh knee fem m rgt;jec3a, 64813112;mrh tibial b/plt keel med 2;unknown, 5560-s-315;triathlon cemented stem-15mm x 150mm;0065987a, 5560-s-215;triathlon cemented stem-15mm x 100mm;0101904a, 64812120;mrh axle;ctd48250, 64812100;mrh tib rot comp xs-xl;167646, 64812110;mrhk femoral bushing;ljs667, 64812140;mrhk tibial sleeve;ljt791, 64812110;mrhk femoral bushing;ljx051, 64812133;mrhk bumper insert 3 degrees;ljs111.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.Reported event: an event regarding infection involving a mrh insert was reported.The event was not confirmed.Method & results: device evaluation and results: not performed as the reported device was not returned for evaluation.Clinician review: not performed as no medical records were received for review with a clinical consultant.Device 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.Conclusion: all stryker products sold as sterile are validated to a minimum sterility assurance level (sal) of 10^-6 in accordance to applicable iso standards.The exact cause of the event could not be determined because insufficient information was provided.¿ additional information including pathology reports, operative reports, 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.¿¿ 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 or Problem Description
This pi is for the revision on (b)(6) 2020.Patient underwent primary tka outside of cors scope.Had a revision tka for pji on (b)(6) 2018.With exchange of polyethylene only.The patient had recurrence of infection and had a revision tka on (b)(6) 2020.Where all components were exchange (pre-cors scope and poly).This was reported as cors per 10467knee ((b)(6)).Patient had again recurrence of pji and underwent another revision where all the hinge components were exchanged.

• Brand Name: MRHK TIB INS 10MM M/L M2/L2
• Common Device Name: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 11370942
• Report Number: 0002249697-2021-00323
• Device Sequence Number: 11705632
• Product Code: MBH
• UDI-Device Identifier: 07613327043822
• UDI-Public: 07613327043822
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K994207
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/24/2021

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: 09/30/2024
• Device Model Number: 6481-3-310
• Device Catalogue Number: 64813310
• Device Lot Number: LJM172
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/29/2021
• Initial Report FDA Received Date: 02/24/2021
• 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: 80 YR
• Patient Weight: 82