MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 25MM MOD REV HIP BODY/BOLT STDCOMPONENT LEVEL 9006-1-025; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	6276-1-025
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/24/2025
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
It was reported that the patient's left hip was revised due to the trunnion of the restoration modular cone body fracturing approximately 1/4 inch to 1/2 inch back from the femoral head.The head and proximal body were revised.Rep will provide all available information when pi confirmation is sent.
Additional Manufacturer Narrative
Reported event an event regarding crack/fracture involving a restoration modular body was reported.The event was confirmed.Method & results -product evaluation and results: visual inspection: the reported device was not returned however photographs were provided for review.The photographs show a recently explanted restoration modular body and metal head.The head remains attached to the fractured neck.From the photographs provided the event can be confirmed.Material analysis, 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 first x-ray shows an intact restoration modular stem with trochanteric wires.The second x-ray shows a restoration modular stem with a fracture through the trunnion that is displaced and angulated.A restoration modular stem with a complete fracture through the trunnion is confirmed.The root cause for this mechanical complication cannot be determined from the documentation provided.Should further documentation become available, i would be happy to further this investigation.' -product history review: review of the product history records indicate the reported device was manufactured with no reported relevant discrepancies.-complaint history review: there have been no other similar events for the lot referenced.Conclusions: it was reported that the patient's left hip was revised due to the trunnion of the restoration modular cone body fracturing approximately 1/4 inch to 1/2 inch back from the femoral head.The head and proximal body were revised.A review of the provided medical records by a clinical consultant indicated: 'the first x-ray shows an intact restoration modular stem with trochanteric wires.The second x-ray shows a restoration modular stem with a fracture through the trunnion that is displaced and angulated.A restoration modular stem with a complete fracture through the trunnion is confirmed.The root cause for this mechanical complication cannot be determined from the documentation provided.The reported device was not returned however photographs were provided for review.The photographs show a recently explanted restoration modular body and metal head.The head remains attached to the fractured neck.From the photographs provided the event can be confirmed.No further investigation for this event is possible at this time.If additional information become available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
No new information.

• Brand Name: 25MM MOD REV HIP BODY/BOLT STDCOMPONENT LEVEL 9006-1-025
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• 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: anna ryan ; raheen business park; limerick NA ; EI NA ; 61498200
• MDR Report Key: 22834516
• Report Number: 0002249697-2025-00887
• Device Sequence Number: 13119406
• Product Code: LPH
• UDI-Device Identifier: 04546540641090
• UDI-Public: 04546540641090
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K121308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/19/2025

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 Catalogue Number: 6276-1-025
• Device Lot Number: 89266101
• 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: 07/24/2025
• Supplement Date Received by Manufacturer: 11/30/2025
• Initial Report FDA Received Date: 08/18/2025
• Supplement Report FDA Received Date: 12/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/19/2022
• 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: 72 YR
• Patient Sex: Male