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

Catalog Number UNK HIP FEMORAL STEM

Device Problems Loss of Osseointegration (2408); Osseointegration Problem (3003)

Patient Problems Unspecified Infection (1930); Inadequate Osseointegration (2646); No Code Available (3191)

Event Date 01/01/2016

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, "twenty-five- to twenty-seven-year results of a cemented vs a cementless stem in the same patients younger than 50 years of age" written by young-hoo kim, md , jang-won park, md, jun-shik kim, md, and in-woo kim, md published by the journal of arthroplasty 31 (2016) 662-667 was reviewed.The article's purpose: "the purpose of the study is to determine (1) validated outcome scores, (2) prevalence of polyethylene wear and osteolysis, and (3) survivorship of the cemented vs cementless femoral components in the same young patients at minimum follow-up of 25 years." data is compiled from 171 patients who received simultaneous bilateral tha with cemented stem in one hip and cementless stem in the other between february 1988 and june 1990 with a mean follow up duration of 26.1 years.Depuy products utilized: elite stem with cement plug in cemented group, profile stem in cementless group, duraloc cup in all hips and poly liner in all hips.Femoral bearing is unidentified but presumed to be depuy product.Cement product is unknown.The article reports on generalized adverse events and provides one patient identified in radiographic image which is captured on a linked complaint.The article reports no hips had an isolated liner change indicating that cup, liner and head were all exchanged during revisions associated not associated with femoral stem.The article reports that all cases of revision were changed to coc bearing surface.The article provides quantities: 74 acetabular components revised, 7 femoral components in cemented and 8 femoral components in cementless this complaint captures the generalized adverse events: cemented group revisions due to stem loosening, liners revised due to osteolysis associated with poly wear (no mention of debris), liners revised due to recurrent dislocation; cementless group had revisions for stem loosening, revision for infection, liner exchanged due to osteolysis associated with poly wear (no mention of debris).

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary
=
> no device was received.Root cause undetermined.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may 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 STEM
• Type of Device: HIP FEMORAL STEM
• 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 ; 700 orthopaedic drive; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 9296883
• MDR Text Key: 183372266
• Report Number: 1818910-2019-111010
• Device Sequence Number: 1
• Product Code: KXA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/15/2019

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 STEM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/15/2019
• Initial Date FDA Received: 11/08/2019
• Supplement Dates Manufacturer Received: 01/08/2020
• Supplement Dates FDA Received: 01/08/2020
• 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