MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN HIP FEMORAL STEM

Catalog Number UNK HIP FEMORAL STEM

Device Problem Loss of or Failure to Bond (1068)

Patient Problem Bone Fracture(s) (1870)

Event Date 11/25/2020

Event Type  Injury  

Manufacturer Narrative

Product complaint #: (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that the patient underwent a proximal femoral replacement revision due to a periprosthetic fracture below her cemented endurance femoral hip stem.Endurance stem was removed and replaced with a competitors proximal femoral replacement stem.Patient's pinnacle constrained liner, which was well fixed, was exchanged for a new constrained liner also.Loosening was indicated at the implant to bone interface.Cement manufacturer was unknown.No surgical delay.Doi: 2007; dor: (b)(6) 2020; left hip.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary no device associated with this report was received for examination.Examination of the provided x-ray images confirms a major bone fracture at the distal tip of the implanted stem.Based on the severity of the fracture it is not unreasonable to confirm the reported loosening.The root cause for the fracture cannot be determined.The information received will be retained for potential series investigations if triggered by trend analysis or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed, and the investigation will be re-opened as necessary.Device history lot a device history record (dhr) review, was not possible because the required lot code(s) was not provided.H10 additional narrative:.

• Brand Name: UNKNOWN HIP FEMORAL STEM
• Type of Device: HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10980385
• MDR Text Key: 220639826
• Report Number: 1818910-2020-26663
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 11/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP FEMORAL STEM
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 12/14 ARTICUL 40MM M SPEC+8.5; PINN LNR CON +4 NEUT 40IDX68OD
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR