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

Catalog Number UNK HIP FEMORAL HEAD

Device Problems Corroded (1131); Degraded (1153); Naturally Worn (2988)

Patient Problems Foreign Body Reaction (1868); Necrosis (1971); Tissue Damage (2104); Injury (2348); No Code Available (3191)

Event Date 05/30/2018

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.(b)(4).

Event Description

"the literature article entitled, ""risk factors associated with early complications of revision surgery for head-neck taper corrosion in metal-on-polyethylene total hip arthroplasty"" written by young-min kwon, md, phd, daniel rossi, md, john macauliffe, meng, yun peng, phd, paul arauz, phd published by the journal of arthroplasty accepted by publisher 30 may 2018.The article's purpose was to "" report the early complication rates and the outcomes of revision surgery, and identify potential risk factors associated with complications of revision surgery for altr associated with head neck taper corrosion, in patients with mop tha."" the data was compiled from 40 patients with various depuy and non depuy products.The article reports on generalized adverse events without patient or identifiers and then lists case identifiers in table 1 with a quantity of 3 cases identified with depuy products (case 4, case 5 and case 6) that are captured individually in linked complaints.Depuy products: summit or trilock stem, cocr femoral head, poly liner, pinnacle cup" this complaint captures case no 5 with a pinnacle cup, poly liner, cocr head and trilock stem that was revised for unknown reason and intraoperative findings were black metal debris at the femoral component trunnion neck taper and the on the bore of the femoral head "grossly indicating corrosion of the head-neck taper junction.Debridement for necrotic periarticular soft tissue, muscle and bone secondary to altr from head-neck taper corrosion.Stem left in intact.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary
=
> no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed, and the investigation will be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• 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 46582
• Manufacturer Contact: kara ditty-bovard ; 1210 ward avenue; west chester, PA 19380-0988 ; 6103142063
• MDR Report Key: 9452860
• MDR Text Key: 185100969
• Report Number: 1818910-2019-122482
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2019
• 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: 01/13/2020
• 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