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

Catalog Number UNK HIP FEMORAL STEM

Device Problem Use of Device Problem (1670)

Patient Problem Pain (1994)

Event Type  malfunction  

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

Literature article entitled "the elite plus total hip arthroplasty-the need for radiological surveillance¿ by n.P.Walton et.Al, published in the journal of bone and joint surgery(br)2005; 87-b:458-62 was reviewed for mdr reportability.The study analyzed the medium-term outcome of the elite plus total hip arthroplasty system.217 patients with 234 thas underwent an elite plus tha with a 28 mm ortron 90 head during 1995 and were clinically followed.Competitor cement was used.1 of the thas immediately post-op was graded c or d based on criteria of barrack, mulroy, and harris indicating loosening though this cannot be confirmed until revision.19 acetabular progressive radiolucent lines were noted on xray at followup though once again, loosening cannot be confirmed until revision.Of the 217 patients (234 thas) the following events were identified: 9 patients were revised for unknown reason prior to followup.52 thas showed either definite evidence of loosening of the component or had been revised for loosening of the component within 6 years.48 stems were noted to be mispositioned in varus/valgus.The article indicated that 39 patients died prior to follow-up but no cause noted nor indication it was product related.The previous article reviewed was published in 2006.After review of updated study published in 2009, the following additional adverse events were noted: 1 revision due to early deep infection.Pain attributed to multiple cases of loosening.3 patients were revised for loosening of the acetabular component.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.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 code(s) 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.Corrective action was not indicated.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 STEM
• Type of Device: HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 8732677
• MDR Text Key: 152031326
• Report Number: 1818910-2019-96801
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Type of Report: Initial,Followup
• Report Date: 06/06/2019

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
• Initial Date Manufacturer Received: 06/06/2019
• Initial Date FDA Received: 06/25/2019
• Supplement Dates Manufacturer Received: 08/13/2019
• Supplement Dates FDA Received: 08/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1