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

Catalog Number UNK HIP FEMORAL STEM

Device Problems Fracture (1260); Migration or Expulsion of Device (1395); Loss of Osseointegration (2408); Osseointegration Problem (3003); Migration (4003)

Patient Problems Bone Fracture(s) (1870); Unspecified Infection (1930); Pain (1994); Inadequate Osseointegration (2646); No Code Available (3191)

Event Date 01/01/2002

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, "the odyssey of porous-coated fixation" written by charles a.Engh, sr., md and robert h.Hopper, jr., phd published by the journal of arthroplasty vol.17 no.4 suppl.1 2002 was reviewed.The article's purpose was to review experience with femoral fixation using proximally and extensively porous-coated variants of the depuy stems.Data was compiled from 2,854 stems implanted between 1977 and 1998.The article does not identify which specific product platforms are associated with the adverse events.The article does not provide adequate information to determine accurate quantities.Depuy products utilized: non-modular and modular aml stems, prodigy stems, solution stems, metal femoral heads, cup (platform not identified), poly liner adverse events: revisions for the following reasons: loose stem (with evidence of migration), infection, pain, implant stem fracture, recurrent dislocation, leg-length inequality, periprosthetic femoral fracture (during immediate postoperative period), loose cup, and poly liner exchange for wear (associated with osteolysis).

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.

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.

• 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 ; 1210 ward avenue; west chester, IN 46581-0988 ; 6103142063
• MDR Report Key: 9432046
• MDR Text Key: 185009974
• Report Number: 1818910-2019-121569
• 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: health professional,literatur
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP FEMORAL STEM
• 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?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention