MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH MOD CON DIST STEM 14 X 195 MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	6276-7-114
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Ambulation or Postural Difficulties (2544)
Date of Event	12/13/2022
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.Device not returned to the manufacturer.
Event or Problem Description
Its reported that implant was broken and revision performed.
Additional Manufacturer Narrative
Reported event: an event regarding crack/fracture and periprosthetic fracture involving a restoration modular stem was reported.The event was confirmed via evaluation of provided photographs of the device and clinician review of provided medical records.Method & results: product evaluation and results: the reported device was not returned however photographs were provided for review.The photograph shows a recently explanted restoration modular construct.The stem has fractured at approximately the midway point.The body and head appear undamaged and unremarkable.Clinician review: a review of the provided medical information by a clinical consultant indicated: "x-rays that are undated and unlabeled show a major revision hip surgery with presence of a long claw plate laterally and evidence of old and perhaps present bony fracture.Most importantly there is a fracture of the femoral metallic stem at the mid 1/3-distal 1/3 junction of the implant.Conclusion/assessment: a metallic implant failure with fracture of the cone conical stem at its mid 1/3-distal 1/3 junction was noted on x-ray.The pi report indicated that revision was pending.Event confirmation: the stem fracture can be confirmed.Root cause: a root cause cannot be ascertained without additional medical information.That said, the metal failure appears to be just below likely ununited bony fracture that could lead to high loads and a cantilever bending moment on the stem that led to fatigue failure." 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.Conclusions: it was reported that the patient was revised due to fracture of the restoration modular stem.The reported event was confirmed via review of the provided photographs of the explanted devices.Clinician review of the further confirmed the event and indicated the following: "a root cause cannot be ascertained without additional medical information.That said, the metal failure appears to be just below likely ununited bony fracture that could lead to high loads and a cantilever bending moment on the stem that led to fatigue failure." 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
Its reported that implant was broken and revision performed.

• Brand Name: MOD CON DIST STEM 14 X 195 MM
• 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: marisol santiago ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 16118570
• Report Number: 0002249697-2023-00019
• Device Sequence Number: 6867350
• Product Code: LPH
• UDI-Device Identifier: 07613154058600
• UDI-Public: 07613154058600
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K013106
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 03/13/2023

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: 01/31/2022
• Device Model Number: 6276-7-114
• Device Catalogue Number: 6276-7-114
• Device Lot Number: CAXV50YF
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/13/2022
• Supplement Date Received by Manufacturer: 02/21/2023
• Initial Report FDA Received Date: 01/06/2023
• Supplement Report FDA Received Date: 03/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2017
• 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: 54 YR
• Patient Sex: Female