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

Catalog Number UNK HIP FEMORAL AUGMENT

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

Patient Problems Nerve Damage (1979); Limb Fracture (4518); Physical Asymmetry (4573)

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

Article entitled "two kinds of total hip arthroplasty for the treatment of adult unilateral crowe iv type hip dysplasia" written by mei xiaoliang, zhang zhenxiang, tong jian, zhu wei, and zhao jianning was reviewed.The aim of the study was to compare the clinical efficacy of two kinds of total hip arthroplasty (tha) for the treatment of adult crowe iv type hip dysplasia (ddh) without osteotomy and subtrochanteric osteotomy.This study retrospectively analyzed 35 adult patients with crowe iv ddh who underwent tha from january 2014 to october 2017.The patients were treated with biotype prosthesis through posterolateral approach, in which common biotype prosthesis stem (johnson & johnson, usa) was used for the femoral side in non-osteotomy group, and s-rom group matching femoral stem (johnson & johnson, usa) was used for the femoral side in subtrochanteric osteotomy group.Non-osteotomy group had 2-3 screws for acetabular fixation.Osteotomy group had one hollow screw.Adverse events: in the non-osteotomy group, there was 1 case of sciatic nerve traction injury and 1 case of femoral neurocutaneous nerve branch injury after surgery, which recovered spontaneously without sequelae.In the subtrochanteric osteotomy group, there were 3 cases of femoral split fracture, which were fixed with steel wire and followed by bed rest for 3 months and late ambulation.In the subtrochanteric osteotomy group 1 case of hip dislocation occurred in the subtrochanteric osteotomy group 1 week after surgery, and no re-dislocation occurred after closed reduction (age 46-year-old male).Leg length discrepancy was noted in both groups.No intervention was noted.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary
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> 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
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> a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.

• Brand Name: UNKNOWN HIP FEMORAL AUGMENT
• Type of Device: HIP FEMORAL AUGMENT
• 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: 14757656
• MDR Text Key: 294940386
• Report Number: 1818910-2022-11386
• Device Sequence Number: 1
• Product Code: HWT
• 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: 06/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP FEMORAL AUGMENT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer 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