MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH MOD CON DIST STEM 14 X 155 MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	6276-7-014
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Pain (1994)
Date of Event	03/21/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The following was reported: "last thursday (b)(6)2024, the patient was transferred to us from the christliches klinikum unna with a periprosthetic fracture with implant fracture, which we operated on friday (b)(6) 2024.The patient stated that she had been experiencing increased muscle pain in her right leg since (b)(6)march 2024.However, she could not recall any trauma or incident of any kind.She said it got progressively worse.It was diagnosed radiologically on the preadmission day for treatment of the left coxarthrosis.".
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.
Event or Problem Description
The following was reported: "last thursday (b)(6) 2024, the patient was transferred to us from the christliches klinikum unna with a periprosthetic fracture with implant fracture, which we operated on friday(b)(6)2024.The patient stated that she had been experiencing increased muscle pain in her right leg since (b)(6) 2024.However, she could not recall any trauma or incident of any kind.She said it got progressively worse.It was diagnosed radiologically on the preadmission day for treatment of the left coxarthrosis.".
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: "confirmation of event: i can confirm that the patient had implantation with a restoration modular femoral component and ceramic head with a cementless cup since i was able to see a prerevision x-ray with the implant in place, albeit fractured.I can confirm that the patient had explantation of the prosthesis with revision with a competitor component because i was able to review the translated operation report.Root cause analysis: the root cause of this event cannot be determined with certainty.The causes of periprosthetic fracture are multifactorial as are the causes of femoral stem fracture.These factors include surgical technique in the way that the implant is secured and positioned, the quality of the bone envelope surrounding the implant, the patient's lifestyle, activity level and bmi as well as implant factors.It is possible that given the poor quality of the patient's bone that there was not adequate support surrounding the implant which could have led to a stress fracture and breakage." -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 further confirmed the event and indicated the following: "the root cause of this event cannot be determined with certainty.The causes of periprosthetic fracture are multifactorial as are the causes of femoral stem fracture.These factors include surgical technique in the way that the implant is secured and positioned, the quality of the bone envelope surrounding the implant, the patient's lifestyle, activity level and bmi as well as implant factors.It is possible that given the poor quality of the patient's bone that there was not adequate support surrounding the implant which could have led to a stress fracture and breakage." 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: MOD CON DIST STEM 14 X 155 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: anna ryan ; raheen business park; limerick NA ; EI NA ; 61498200
• MDR Report Key: 19122538
• Report Number: 0002249697-2024-00608
• Device Sequence Number: 7641336
• Product Code: LPH
• UDI-Device Identifier: 04546540643728
• UDI-Public: 04546540643728
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K121308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/04/2024

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: 08/31/2024
• Device Catalogue Number: 6276-7-014
• Device Lot Number: CAXX94D
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/26/2024
• Supplement Date Received by Manufacturer: 08/08/2024
• Initial Report FDA Received Date: 04/16/2024
• Supplement Report FDA Received Date: 09/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/24/2019
• 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: 83 YR
• Patient Sex: Female