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 Ossification (1428); Bone Fracture(s) (1870); Unspecified Infection (1930); Pain (1994); Inadequate Osseointegration (2646); No Code Available (3191)

Event Type  Injury  

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

(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, "revision total hip replacement using the s-rom femoral component" written by hugh p.Chandler, md, douglas k.Ayres, md, raymond c.Tan, ms, lars c.Anderson, bs, and ashok k.Varma, md published by clinical orthopaedics and related research number 319 pp.130-140 1995 was reviewed.The article's purpose to present authors' experience using a proximally porous-coated, modular femoral prosthesis in very complex revision total hip arthroplasties that often included major femoral reconstruction using structural allografts.Data was compiled from 52 revisions in 48 patients utilizing srom prosthesis between 1989 to 1992.Average age of patients was 60 all had difficult problems including average of 3 previous hip operations and previous resection arthroplasty for deep sepsis.Surgeons cemented the sleeve to structural allografts in 14 hips and 1 patient had cement utilized with the stem.The majority of patients had cementless femoral components implanted.Depuy products utilized: srom prosthesis hip system and mop bearing surfaces, cup fixation screws adverse events: pain (thigh, groin, and hip locations), loose acetabular cup (treated by revision), dislocations (treated by closed reductions and revisions), heterotopic ossification limiting range of motion (treated with surgical intervention), loose femoral component (treated by revision), infection(treated by revision), post op femoral fracture (treated by revision), re-revision revealed poly wear with poly debris but no metallic fragments, during a re-revision metallic debris is "noted around the metal shell and anchoring screws of a loose acetabular component" the article does not provide adequate information to determine accurate quantities.

• 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, PA 19380-0988 ; 6103142063
• MDR Report Key: 9396318
• MDR Text Key: 184745772
• Report Number: 1818910-2019-119020
• 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
• Report Date: 11/07/2019

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: 11/07/2019
• Initial Date FDA Received: 12/02/2019
• Supplement Dates Manufacturer Received: 12/12/2019
• Supplement Dates FDA Received: 12/23/2019
• 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