MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN HMRS TIBIAL STEM; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	6495-5-011
Medical Device Problem Codes	Degraded (1153); Fracture (1260)
Health Effect - Clinical Codes	Ambulation or Postural Difficulties (2544); Insufficient Information (4580)
Date of Event	09/25/2008
Type of Reportable Event	Serious Injury
Event or Problem Description
This pi is for the revision surgery performed on (b)(6) 2008.Patient underwent resection surgery in 1989 proximal right tibia and reconstruction with hmrs modular prosthesis stryker for osteosarcoma.On b)(6) 2008 surgery for revision of the tibial prosthetic component due to stem rupture.On that occasion, the patient replaced the hmrs tibial stem with gmrs stryker tibial stem (ref 6495-5-011, lot 7w4074a) and fitted new tibial prosthetic body by implanting hmrs 120mm tibial prosthetic corope, gmrs tibial prosthetic tense adapter, and gmrs 50mm tibial spacer (no replacement of femoral component which was intact).On (b)(6) 2016 surgery replacement of right knee prosthetic joint components due to wear and tear.On (b)(6) 2016 surgical cleanup for infection peri-prosthetic tibial, retaining tibial stem, and implantation of antibiotic cement spacer.On (b)(6) 2017 also explantation of femoral prosthetic component and further surgical cleaning with cement spacer renewal.On 24/mar/2017 and 19/may/2017 renewal cement spacer.On (b)(6) 2017 implantation of modular tibia prosthesis proximal dx in knee arthrodesis also using component custom gmrs extension piece (ref c-m106-2-000; lot tagw401).In march 2025 onset of acute pain right leg in absence of obvious trauma.X-ray performed on (b)(6) 2025 thigh and right leg showing rupture of tibial prosthetic stem.For this reason on (b)(6) 2025 underwent amputation surgery transfemoral dx with complete removal of the prosthetic implant.
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.
Event or Problem Description
No new information.
Additional Manufacturer Narrative
Reported event: an event regarding crack/fracture involving an unknown hmrs tibial stem 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: not performed as no information was provided for review.-product history review: could not be performed as lot code information was not provided.-complaint history review: could not be performed as lot code information was not provided.Conclusions: it was reported that revision surgery took place due to stem fracture.The event was not confirmed.The exact cause of the event could not be determined because insufficient information was provided.Additional information including 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.Correction: d1, d4, h4 will be unknown and g1 corrected based on the updated received both catlog and lot numbers unknown.

• Brand Name: UNKNOWN HMRS TIBIAL STEM
• 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 NJ NA ; EI NA
• Manufacturer Contact: arokiya raj ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 22131464
• Report Number: 0002249697-2025-00575
• Device Sequence Number: 20921172
• Product Code: KRO
• UDI-Device Identifier: 07613327033489
• UDI-Public: 07613327033489
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K031217
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 1989
• Device Explanted Year: 2008
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/13/2025

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: 06/30/2013
• Device Catalogue Number: 6495-5-011
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/12/2025
• Supplement Date Received by Manufacturer: 09/16/2025
• Initial Report FDA Received Date: 06/03/2025
• Supplement Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/04/2008
• 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 Sex: Unknown