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); Noise, Audible (3273)

Patient Problems Unspecified Infection (1930); Joint Dislocation (2374); No Code Available (3191)

Event Date 03/30/2016

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, "long-term results of third-generation ceramic-on-ceramic bearing cementless total hip arthroplasty in young patients" written by young-hoo kim, md, jang-won park, md, and jun-shik kim, md published by the journal of arthroplasty (2016) accepted by publisher on 30 march 2016 was reviewed.The article's purpose: "the purpose of this study was to determine: (1) long-term clinical and radiologic outcome, (2) how many lesions of osteolysis could be detected with radiographs and computerized tomographic (ct) scan, and (3) survivorship of a cementless tha using a third-generation alumina-on-alumina ceramic bearing in 871 active patients aged younger than 65 years." depuy products utilized: duraloc cup, ceramic liner, ceramic head, ips stem - all patients received depuy products adverse events: limb discrepancy (average.8 cm no interventions), clicking or squeaking sound (no interventions), dislocation (treated with closed reduction and bracing; revision of acetabular component), deep early postoperative infection (treated by debridement and exchange of the femoral head and liner along with iv antibiotics), undisplaced intraoperative fracture of calcar femorale (treated with cable intraoperatively without sequelae) the article does not provide adequate information to determine accurate quantities of impacted products.

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 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 46582
• Manufacturer Contact: kara ditty-bovard ; 1210 ward avenue; west chester, PA 19380-0988 ; 6107428552
• MDR Report Key: 9282990
• MDR Text Key: 184834410
• Report Number: 1818910-2019-114308
• 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,literature
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP FEMORAL HEAD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/07/2020
• 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