MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 25MM MOD REV HIP BDY/BLT +10MMCOMPONENT LEVEL 9006-1-125; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	6276-1-125
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Pain (1994); Ambulation or Postural Difficulties (2544)
Date of Event	08/19/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The following devices were also listed in this report: mod con dist stem 15 x 155 mm; cat#: 6276-7-015.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 crack/fracture involving a restoration modular body 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: no medical records were received for review with a clinical consultant.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 referenced.Conclusion: the exact cause of the event could not be determined because insufficient information was provided.Further information such as photographs or return of the device, pathology reports, pre- and post-operative x-rays and the revision operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.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
It was reported by the patient that on (b)(6) 2014, he underwent revision surgery and was implanted with a restoration modular hip system.In late on (b)(6) 2024 he started to experience extreme pain in his right upper leg femur area and had difficulty standing or walking.He was revised on (b)(6) 2024, allegedly due to the tip of the prosthesis broke off inside his femur.
Event or Problem Description
Update per patient call: patient reported that they had a second revision with stryker implants on (b)(6) 2024 for pain.They further stated that it was noted during the procedure that the tip of the prosthetic in the femur had broken off and come loose.The broken piece at the very distal end of the femoral component was left in the patient.Right hip.
Additional Manufacturer Narrative
An event regarding crack/fracture involving a restoration modular body 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: "if we assume that the information that i received in the document supplied by the patient is accurate then i can confirm that the patient had an initial primary total hip arthroplasty in 2012, a revision in 2014 and yet a further revision in 2024 since i was able to see xrays with handwritten dates.Root cause analysis: assuming that the event was failure of the initial primary total hip arthroplasty that was performed with the rejuvenated implant, the root cause cannot be determined with certainty.The root cause of failure of the primary implant cannot be determined unless there is specific information regarding the failure mode.Of course there is a history of the rejuvenate implant failing due to trunnionosis, etc.I cannot implicate this since i have no information other than the patient's narrative.If we could absolutely confirm that the failure mode was due to failure at one or both of the trunnion's than causality could be attributed to surgical technique in the way that the modular femoral neck was prepared as well as the receiving portion of the femoral component, as well as patient lifestyle, activity level and bmi as well as implant factors." -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 referenced.Conclusion: it was reported that the patient was revised due to device fracture.A review of the provided medical records by a clinical consultant indicated: "if we assume that the information that i received in the document supplied by the patient is accurate then i can confirm that the patient had an initial primary total hip arthroplasty in 2012, a revision in 2014 and yet a further revision in 2024 since i was able to see xrays with handwritten dates.Root cause analysis: assuming that the event was failure of the initial primary total hip arthroplasty that was performed with the rejuvenated implant, the root cause cannot be determined with certainty.The root cause of failure of the primary implant cannot be determined unless there is specific information regarding the failure mode.Of course there is a history of the rejuvenate implant failing due to trunnionosis, etc.I cannot implicate this since i have no information other than the patient's narrative.If we could absolutely confirm that the failure mode was due to failure at one or both of the trunnion's than causality could be attributed to surgical technique in the way that the modular femoral neck was prepared as well as the receiving portion of the femoral component, as well as patient lifestyle, activity level and bmi as well as implant factors." 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.

• Brand Name: 25MM MOD REV HIP BDY/BLT +10MMCOMPONENT LEVEL 9006-1-125
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NA ; EI NA
• Manufacturer Contact: brad curtis ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 21631315
• Report Number: 0002249697-2025-00310
• Device Sequence Number: 7424746
• Product Code: LPH
• UDI-Device Identifier: 04546540643735
• UDI-Public: 04546540643735
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K121308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/04/2026

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: 08/31/2018
• Device Catalogue Number: 6276-1-125
• Device Lot Number: 44323005
• 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: 02/25/2025
• Supplement Date Received by Manufacturer: 02/12/2026
• Initial Report FDA Received Date: 03/18/2025
• Supplement Report FDA Received Date: 03/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/07/2013
• 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: Required Intervention; Hospitalization
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 97 KG