MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 UNKNOWN HIP FEMORAL STEM

Catalog Number UNK HIP FEMORAL STEM

Device Problem Migration (4003)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

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.This report pertains to six instances of the same product.Concomitant medical products: unknown hip femoral head; unknown hip cement restrictor; unknown hip cemented acetabular all-poly cup; unknown hip cemented femoral stem; unknown bone cement.

Event Description

Complaint description: literature (depuy).Literature article: "the migration pattern of the charnley femoral stem: a five year follow-up rsa study in a well functioning group" by kristin haugan, otto s.Husby, jomar klaksvik, and olav a.Foss.The five year study followed 36 total hip replacements using the charnley flanged 40 stem, manufactured with tantalum beads mounted on stainless steel towers, at the stem proximal shoulder and distal stem tip.The beads allowed for rsa (radiosterometric analysis) of the positions of the stems over time.Patients also received charnley ogee cemented cups.Depuy cement restrictors were used for pressurising cement.Depuy smartset hv cement was used for 18 of the 36 total, with a competitor brand used for the other 18.At the conclusion of the study, only 23 hips were available for follow-up.It was determined that through rsa that the charnley stems migrated and retroverted to small degrees over the course of the five years.It is to be noted though that both with regard to the 23 hips that concluded the study, and for those that did not, none required revision surgery for any complications.It also should be noted that 4 patients did not complete the study due to deaths unrelated to the study.It was identified that the charnley cemented femoral stems of six patients subsided and internally rotated, but none of the patients required intervention or revision surgery.

Manufacturer Narrative

Product complaint # : (b)(4).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.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 STEM
• Type of Device: HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46582-0988 ; 5743725905
• MDR Report Key: 7910918
• MDR Text Key: 122003664
• Report Number: 1818910-2018-70578
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: NO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP FEMORAL STEM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/26/2018
• Initial Date FDA Received: 09/26/2018
• Supplement Dates Manufacturer Received: 09/27/2018
• Supplement Dates FDA Received: 09/28/2018
• 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