MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH MRHK TIB INS 10MM XS/S S1/S2; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number	6481-3-210
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	03/16/2022
Type of Reportable Event	Serious Injury
Additional 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.Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.Catalog numbers and lot codes of other devices listed in this report: 64811110, mrh knee fem s lft, lot a434d, 64786625, ti dur reg fluted stem 15x80mm, lot 101168, b000-0240 ,md.Universal cement restrictor , lot 6m9974, 64812110, mrhk femoral bushing ,qty 2 , lot lkf396, 64812100 ,mrh tib rot comp xs-xl , lot 172811a, 64812120, mrh axle, lot ctd48225, 64812130 ,mrhk bumper insert - neutral , lot lkf417, 6495-5-011, 11mm press fit fluted stem, lot 204301c, 64953102 ,gmrs proximal tibial standard, lot 154830a, 64812140 ,mrhk tibial sleeve, lot lke108, unknown, 210-004-000 femoral canal brush for use with interpulse,and lot 20051012.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.
Event or Problem Description
A stanmore patient specific prescription form was provided for the patient's left knee.Noted on the form: "for infected proximal tibia gmrs." proposed date of surgery is (b)(6)2022.
Additional Manufacturer Narrative
Reported event: an event regarding infection involving a mrh insert was reported.The event was not confirmed.Method & results: product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.Clinician review: a review of the provided medical records by a clinical consultant indicated the following: "it is confirmed that a 13-year-old jordanian arab female underwent a limb salvage surgery with subsequent limb selvage surgery with a stryker rotating hinge mega prosthesis.3 weeks post subsequently the surgical wound dehisced and got infected.It is my assessment that the stryker prosthesis is not the cause of this complication.Limb salvage surgery itself carries a higher rate of infection than a primary knee surgery.This is further complicated by adjuvant chemotherapy which can interfere with or delay wound healing.In addition chemotherapy it can cause immunocompromise leading.To greater risk for infection." product history review: review of the device history records indicate 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 lot or sterile lot referenced.Conclusion: it was reported that the patient was revised due to infection.A review of the provided medical records by a clinical consultant indicated the following: "it is confirmed that a 13-year-old jordanian arab female underwent a limb salvage surgery with subsequent limb selvage surgery with a stryker rotating hinge mega prosthesis.3 weeks post subsequently the surgical wound dehisced and got infected.It is my assessment that the stryker prosthesis is not the cause of this complication.Limb salvage surgery itself carries a higher rate of infection than a primary knee surgery.This is further complicated by adjuvant chemotherapy which can interfere with or delay wound healing.In addition chemotherapy it can cause immunocompromise leading.To greater risk for infection." all stryker products sold as sterile are validated to a minimum sterility assurance level sal of 10^-6 in accordance to applicable iso standards.No further investigation for this event is possible at this time.If devices and/or additional information become available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
A stanmore patient specific prescription form was provided for the patient's left knee.Noted on the form: "for infected proximal tibia gmrs." proposed date of surgery is (b)(6) 2022.

• Brand Name: MRHK TIB INS 10MM XS/S S1/S2
• 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: diana rogers ; 210 centennial avenue; centennial park, elstree; borehamwood WD6 3-SJ ; UK WD6 3SJ ; 2082386500
• MDR Report Key: 14073776
• Report Number: 0002249697-2022-00507
• Device Sequence Number: 5948046
• Product Code: KRO
• UDI-Device Identifier: 07613327043785
• UDI-Public: 07613327043785
• Combination Product (Y/N): N
• Initial Reporter Country: JO
• PMA/510(K) Number: K994207
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2022

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: 11/30/2024
• Device Model Number: 6481-3-210
• Device Catalogue Number: 64813210
• Device Lot Number: LJP797
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/16/2022
• Supplement Date Received by Manufacturer: 11/17/2022
• Initial Report FDA Received Date: 04/11/2022
• Supplement Report FDA Received Date: 12/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/14/2019
• 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: Hospitalization; Required Intervention
• Patient Age: 14 YR
• Patient Sex: Female
• Patient Weight: 55 KG