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

Catalog Number UNK HIP FEMORAL HEAD

Device Problem Naturally Worn (2988)

Patient Problems Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Necrosis (1971); Pain (1994); Osteolysis (2377); No Code Available (3191)

Event Date 03/02/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.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 code(s) was not provided.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.Corrective action was not indicated.(b)(4).

Event Description

"literature article entitled, long-term results of metal on metal total hip arthroplasty in younger patients (< 55yrs)¿ by muhammad umara, et al, published by journal of orthopaedics (2018), vol.15, pp.586-590, was reviewed.The purpose of this study was to determine the survival of mom hip replacement in a population younger than 55 years in 109 hips implanted between 2003-2009.Implanted depuy products: pinnacle cup, metal liner, cocr femoral head, and corail stem.There were 12 revisions, 7 of these were for metallosis and associated symptoms.Average time to revision was 7 years.This complaint captures the detailed revisions in the attached guidance document labeled case 1 through case 12 linked to (b)(4)." patient implanted with a corail stem, pinnacle cup, and mom articulations including a metal liner and cocr 36-mm femoral head.Revised head and liner as well as periarticular debridement 10 years after index procedure due to sypotomatic armd.Intraoperative findings: osteolysis, periarticular soft tissue necrosis consistent with foreign body reaction, and periartcular inflammation and alval consistent with hypersensitivity to metal debris.There were no reported product problems with the cup and stem.The authors note that the mean blood metal ions in patients requiring revision surgery was lower than 7 pp (co 4.3 ppb and cr 6.8 ppb).There is insufficient information provided to determine the blood metal ion level in this patient.

• 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): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic drive; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 9466944
• MDR Text Key: 174858827
• Report Number: 1818910-2019-123014
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2019
• 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
• Date Manufacturer Received: 11/20/2019
• 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