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

Catalog Number UNK HIP FEMORAL HEAD

Device Problems Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bone Fracture(s) (1870); Hematoma (1884); Nerve Damage (1979); Pain (1994); Joint Dislocation (2374); Post Operative Wound Infection (2446); Physical Asymmetry (4573)

Event Date 09/03/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Literature article entitled: ¿analysis of complications in 100 cases of hip joint replacement through direct anterior approach¿, by guo wenli, et.Al., published in chinese journal of bone and joint, september 2017, vol 6, no.9, 10.3969/j.Issn.2095-252x, was reviewed.Authors reported on a retrospective review of the first 100 total hip replacements performed using the direct anterior approach (daa), investigating the complications that occurred in early learning.Sixty-eight hips (59 patients) were treated with total hip arthroplasty, and 41 were treated with hemiarthroplasty, all utilizing daa, and depuy implants: pinnacle cups and liners for total hips, or j&j bipolar heads for hemiarthroplasties; paired with either trilock or corail implants for the stem in both total-and hemiarthroplasty procedures.No other product details were provided, and no patient case specifics were given either, such as case number of age/gender discriminators.The follow-up time was 6-22 months.The following 64 complications were reported to have occurred: 2: greater trochanter avulsion fracture (intraoperative, treated with cerclage orif), 2: calcar bone fractures (intraoperative, treated with cerclage orif), 1: acetabular bone fracture (intraoperative), 2: greater trochanter cutting fractures (intraoperative), 2: superficial incision infections, 2: incision hematoma formation, 9: leg length discrepancies, 20: lateral femoral cutaneous nerve injuries , 23: anterior thigh pain, 1: postop day-1 total hip posterior hip dislocation, followed by anterior hip dislocation (same patient) treated with closed reductions, and hip spica cast for 3 months.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.This complaint was opened to document complaints derived through a journal article review.Follow-ups were done to try and obtain additional information from the author of the journal article.No further information was received.Device history lot : a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.

• Brand Name: UNKNOWN HIP FEMORAL HEAD
• Type of Device: HIP FEMORAL HEAD
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 14852284
• MDR Text Key: 294927808
• Report Number: 1818910-2022-11975
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/29/2022

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?: Yes
• Device Catalogue Number: UNK HIP FEMORAL HEAD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/13/2022
• Initial Date FDA Received: 06/29/2022
• Supplement Dates Manufacturer Received: 08/09/2022
• Supplement Dates FDA Received: 08/09/2022
• 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