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

Catalog Number UNK HIP FEMORAL STEM

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bone Fracture(s) (1870); Thrombosis (2100); No Code Available (3191)

Event Date 12/27/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The literature article entitled, "total hip arthroplasty for intertrochanteric fracture fixation failure" written by liyun liu, yongqiang sun, linlin wang, qiankun gao, ang li, jialin wang and yanzheng gao published by european journal of medical research made available online 27 december 2019 was reviewed.The article's purpose is to describe total hip arthroplasty (tha) salvage treatment of elderly patient suffering intertrochanteric fracture fixation failure with positive clinical outcomes.In all cases, internal fixation was removed and then followed with procedures for tha.Acetabular cups were fixated with 2 screws and either poly or ceramic liners were utilized.The article only identifies stems utilized with 5 patients treated with non-depuy stem and 9 patients treated with depuy stem.Material of femoral head is not discussed.The article does not identify which specific products are associated with the adverse events.During discussion of patients within the study, the article reports of 2 patient deaths- one within 1 month after surgery as a result of acute pulmonary embolism and the other 6 months post surgery due to pulmonary heart disease.However, it does not identify products in these patients and it does not specify the deaths as related to the implantations.Figure 1 and figure 2 provided photographic and radiographic imaging for a 64 year old male and 71 year old male respectively.The figure descriptions suggest the images are to illustrate failed original fixations and successful thas with no related adverse events.Depuy products: solution stem.Adverse events: death from acute pulmonary embolism 1 month post surgery intraoperative femoral trochanter split (treated with steel wire and fixed with tension band) deep vein thrombosis 3 months post surgery (treated successfully).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Product complaint # (b)(4).Investigation summary = no device was received.Root cause undetermined.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.

• 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: 9848332
• MDR Text Key: 184092343
• Report Number: 1818910-2020-08450
• Device Sequence Number: 1
• Product Code: KXA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Type of Report: Initial,Followup
• Report Date: 03/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP FEMORAL STEM
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention