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

Catalog Number UNK HIP FEMORAL HEAD

Device Problems Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993); Noise, Audible (3273)

Patient Problems Ossification (1428); Bone Fracture(s) (1870); Unspecified Infection (1930); Injury (2348); Joint Dislocation (2374); No Code Available (3191)

Event Date 10/30/2007

Event Type  Injury  

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.

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 results of a proximally-coated cementless femoral component in total hip replacement" written by y.H.Kim published by the journal of bone and joint surgery accepted after revision 30 october 2007.The article's purpose was to review the results of a cementless anatomical femoral component to give immediate post-operative stability, and with a narrow distal section in order not to contact the femoral cortex in the diaphysis, ensuring exclusively metaphyseal loading.Data was compiled from 601 hips in 471 patients age ranging 20 to 63 years and consisted of 297 men and 174 women receiving implants between march 1995 and february 2002.All implants were depuy products.The article includes radiographic images.Depuy products: cementless ips stem, duraloc cups (with screw at times), ceramic liner, ceramic femoral head adverse events: clicking sound (no interventions provided) grade 2 and grade 3 stress shielding at calcar (radiographically detected and no interventions) distal pedestals (radiographically detected and no interventions) infection (treated by revision of both acetabular and femoral components) recurrent dislocation (treated by revision of acetabular components) intraoperative calcar fracture (treated with cabling) avulsion fracture of greater trochanter (no interventions provided) grade 2 heterotopic ossification (no functional impact and no interventions provided) figure 2a and 2b provide radiographic imaging of a 38 year old man with grade iii calcar atrophy (no interventions provided).

• Brand Name: UNKNOWN HIP FEMORAL HEAD
• Type of Device: HIP FEMORAL HEAD
• 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
• Manufacturer Contact: kara ditty-bovard ; 1210 ward avenue; west chester, PA 19380-0988 ; 6103142063
• MDR Report Key: 9637938
• MDR Text Key: 185351010
• Report Number: 1818910-2020-03257
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: KS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP FEMORAL HEAD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/27/2020
• 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