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 Thrombosis/Thrombus (4440); Limb Fracture (4518); Joint Laxity (4526)

Event Date 01/01/2022

Event Type  Injury  

Event Description

Article entitled ¿combination prostheses and integral prostheses for the rehabilitation of crowe iii - w developmental myelial dysplasia initial stability "written by li yang, lu hui, huang deng hua, zou longfei, zhang zhongjie, tan meiyun, published by china organization engineering research on 12/14/2021 was reviewed.To explore the advantages and disadvantages of low femoral and neck bone amputee combined with a one-piece prosthesis or a combination prosthesis for the treatment of crowe i-iv developmental hip joint dysplasia.Retrospective analysis of clinical data of 36 patients with crowe itv developmental hip dysplasia admitted to the hospital of september 2015 to august 2019 southwest medical university, 5 male, 31 female, aged 27-64, 19 left-hand side.In the 17 cases on the right, all were treated for total hip replacement.In 18 cases, the integrated wagner cone was used after the lower femoral neck section and in 18 cases the combined s-rom prosthesis was used after the lower femoral neck section.Finding and conclusions: srom femoral i degree stress occlusion (stress fracture) effect 15 cases, ii degree, srom group there was one case of femoral paralysis of 6.7 cm of the limb.There was 1 post-operative development of peroneal thrombosis.Depuy synthes srom modular hip system was used as well as competitor products.In the case of s-rom prostheses, they were fitted with 12 pinnacle hip prostheses.6 cases of gripton-coated hip prostheses, 13 cases of ceramics, 5 cases of ceramics high cross-linked polyethylene.In terms of complications, no dislocation, aseptic loosening and infection around the prosthetic were observed and no significant stress-masking effect was observed at the proximal end of the femur.It is worth mentioning that in the case of s-rom group 2 patients, the initial stability of the posterior prox sleeve was slightly worse, the stability was significantly increased when the sleeve was placed 180° according to the proximal medullary cavity shape.There were no medical interventions/revisions/invasive treatments noted.

Manufacturer Narrative

Product complaint # (b)(4).The device catalog number is unknown; therefore, udi is unavailable.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.

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 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: 15587398
• MDR Text Key: 301567587
• Report Number: 1818910-2022-20184
• Device Sequence Number: 1
• Product Code: JWH
• 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: 10/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2022
• 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: 10/18/2022
• 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