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

Catalog Number UNK HIP FEMORAL HEAD

Device Problems Corroded (1131); Degraded (1153); Device Dislodged or Dislocated (2923)

Patient Problems Joint Dislocation (2374); No Code Available (3191)

Event Date 03/24/2014

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

"the literature article entitled, ""do you have to remove a corroded femoral stem"" written by nitin goyal, md, henry ho, ms, kevin b.Fricka, md, and charles a.Engh jr.Md published by the journal of arthroplasty 29 suppl.2 (2014) 139-142 accepted by publisher 24 march 2014 was reviewed.The article's purpose was to report upon 86 retrieved femoral heads with note of corrosion while leaving a well fixed stem in place regardless of the degree of corrosion.All implants were depuy products without provision of identified platforms.The article reports all retrieved femoral heads were related to revision surgeries associated with poly wear.No further information provided on original revision reasons.The article does not provide information if corrosion was noted on the femoral stem.The article reports after revision surgery and exchange of heads and liners, 7 re-revisions were provided with reasons along with any note of corrosion on femoral head taper which are captured individually in linked complaints.Depuy products utilized: cocr femoral head, poly liner, cocr stem.No information provided for acetabular cup." this complaint captures case 6 that required re-revision 2.19 years from initial revision for recurrent dislocation/subluxation with note of severe corrosion on 2nd retrieved ball.

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.If information is obtained that was not available for the initial medwatch, a follow-up 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: 9411892
• MDR Text Key: 170668907
• Report Number: 1818910-2019-117480
• Device Sequence Number: 1
• Product Code: KXA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/12/2019

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: 11/12/2019
• Initial Date FDA Received: 12/04/2019
• Supplement Dates Manufacturer Received: 01/03/2020
• Supplement Dates FDA Received: 01/07/2020
• 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