MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNK HIP FEMORAL HEAD METAL; METAL FEMORAL HEAD

Catalog Number UNK HIP FEMORAL HEAD METAL

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problems Unspecified Infection (1930); Osteolysis (2377)

Event Date 05/21/2021

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 "comparison of short stem versus conventional stem for hip arthroplasty in patients younger than 60 years: 7¿14 years follow up" written by arnaldo sousa, joão vale, sara diniz, pedro neves, joaquim ramos, and rafaela coelho published by european journal of orthopaedic surgery and traumatology on may 21, 2020, was reviewed.The purpose of this study was to compare functional, radiological and survival results of tha with an ultrashort anatomic metaphyseal-fitting cementless stem (proxima®, depuy johnson & johnson) versus conventional proximal porous-coated cementless stem (taperloc®, zimmer biomet).175 hips were involved in the study.101 being implanted with a proxima stem, pinnacle cup (3 acetabular screws if needed), metal head, and polyethylene line.Adverse event involving depuy ¿ synthes products: one patient sustained an intra-operative calcar fracture that was managed with 2 cerclage cables.One patient underwent a 2-stage revision surgery due to chronic infection 6 years after the index surgery.35 stems were noted to be in varus/valgus ¿ no interventions noted.3 stems were noted have subsided ¿ no interventions noted.47 patients were noted to have stress shielding.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary no device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot number was not provided.Based on previous investigations, this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Device history lot a worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot number was not provided.

• Brand Name: UNK HIP FEMORAL HEAD METAL
• Type of Device: METAL 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: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 12689453
• MDR Text Key: 278160658
• Report Number: 1818910-2021-23441
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: PO
• 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: 10/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP FEMORAL HEAD METAL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/02/2021
• 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