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

Device Problem Fracture (1260)

Patient Problem Bone Fracture(s) (1870)

Event Date 03/21/2024

Event Type  Injury  

Event 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.".

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.

• Brand Name: MOD CON DIST STEM 14 X 155 MM
• Type of Device: 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
• MDR Text Key: 340339892
• Report Number: 0002249697-2024-00608
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 04546540643728
• UDI-Public: 04546540643728
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K121308
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 6276-7-014
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/26/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 83 YR
• Patient Sex: Female