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

Catalog Number UNK HIP FEMORAL HEAD

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Ossification (1428); Joint Dislocation (2374); Unspecified Musculoskeletal problem (4535)

Event Date 01/01/2017

Event Type  malfunction  

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

Article entitled ¿effect of direct anterior total hip arthroplasty for patients with extension ankylosis" written by gong dawei, yang yunkang, chen ge, yao yiran, ren ye, published by shandong medical journal 2017 vol.57 no.29, was reviewed.The articles purpose was to investigate the clinical effect of direct anterior approach (daa) total hip arthroplasty (tha) in the treatment of extension ankylosis of the hip.Methods 81 cases of extension type patients with hip ankylosis were randomly divided into groups for direct daa total hip replacement and posterolateral total hip replacement, respectively.The included patients were unilateral replacement (replacement of severe side first), and the operations were completed by the same senior surgeon.The incision length, operation time, intraoperative blood loss, postoperative drainage volume, hospital stay, single-crutch walking time, and abduction walking time were recorded.Harris score and vas were used to evaluate the hip joint function and pain severity before surgery, after surgery and during follow-up.Imaging evaluation was performed after surgery, and relevant complications were collected.All patients were followed up, with an average follow-up of 23.7%.5 months; compared with group b, group a had shorter incision length, less intraoperative blood loss and postoperative drainage volume, shorter hospital stay, single crutch walking time and abandonment crutch walking time, lower vas 3 d after operation, and higher harris scores 1 and 3 months after operation.Daa total hip arthroplasty can be rapidly reduced in patients with extension hip ankylosis.Complications noted in this study included: 1 femoral bone fracture intraoperatively, treated with wire banding.1 femoral bone fracture intraoperatively, treated with wire banding and implanting longer stem.1 posterior dislocation.4 nerve injury.4 heterotopic ossification.1 acetabular loosening, no intervention reported.There was no revision information provided.Depuy products: using the biotype prosthesis of johnson & johnson (depuy), ceramic-on-ceramic or ceramic-on-high hinge polyethylene friction interface, pinnacle molar cup, corail or trilock biological stem, except for the biotype reinforcement stem selected for intraoperative femoral shaft fracture.

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: 14843674
• MDR Text Key: 303093907
• Report Number: 1818910-2022-11915
• 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: 06/28/2022

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 Operator: Health Professional
• 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: 06/28/2022
• Supplement Dates Manufacturer Received: 07/04/2022
• Supplement Dates FDA Received: 07/05/2022
• 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