MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH MEDIUM KRH ALL POLY TIBIA 16MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	6485-2-216
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Loss of Range of Motion (2032); Ambulation or Postural Difficulties (2544)
Date of Event	01/17/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient's left total femur was revised.As reported: "pt.Presented with loss of function of the left leg after radiation therapy following a total-femur replacement which was revised most recently on (b)(6) 2022.The doctor opted to revise the pt¿s left leg using a ¿tibial turn-up¿ technique.All previous components were explanted, and a cemented-hemiarthroplasty was implanted in order to give the patient a ¿semi-functional hip allowing him to sit-up in a wheel-chair.¿ as per sales rep, all implants implanted in (b)(6) 2022 and an all poly component implanted (b)(6) 2022 were revised.Rep confirmed no further information will be released by the hospital or surgeon.
Additional Manufacturer Narrative
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.An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.The following devices were also listed in this report: cat# uh1-52-26; uhr bipolar 26x52mm; lot# 652aam.Cat# 64956060; gmrs extension piece 60mm; lot# lc73e.Cat# 64812120; mrh axle; lot# ctd65537.Cat# 6260-9-226; 26mm +4 lfit v40 head; lot# 91098007.Cat# 64952030; gmrs dist fem comp std l 65mm; lot# ntn2j.Cat# 64812130; mrhk bumper insert - neutral; lot# llc298.Cat# 64951001; proximal fem comp std; lot# nns4l.Cat# 64812110; mrhk femoral bushing; lot# lks115.Cat# 64956220; gmrs extension piece 220; lot# n4a4y.Cat# 64812110; mrhk femoral bushing; lot# lkr220.Cat# 64956009; gmrs connection piece 90mm lft; lot# ctd65571.64812103; mrh xs/s/m long xover; lot# 168174b.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.Not returned to the manufacturer.

• Brand Name: MEDIUM KRH ALL POLY TIBIA 16MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• 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: joann ripoli ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 16309960
• Report Number: 0002249697-2023-00131
• Device Sequence Number: 20379539
• Product Code: JWH
• UDI-Device Identifier: 07613327047547
• UDI-Public: 07613327047547
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K972863
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/07/2023

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: 01/31/2023
• Device Model Number: 6485-2-216
• Device Catalogue Number: 64852216
• Device Lot Number: RTH0112
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/17/2023
• Initial Report FDA Received Date: 02/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/16/2018
• 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: 67 YR
• Patient Sex: Male