MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN HIP ACETABULAR LINERS

Catalog Number UNK HIP ACETABULAR LINER

Device Problems Device Dislodged or Dislocated (2923); Noise, Audible (3273)

Patient Problems Thrombosis (2100); Joint Dislocation (2374); No Code Available (3191)

Event Date 09/16/2014

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, "outcome of an ultrashort metaphyseal-fitting anatomic cementless stem in highly active obese and non-obese patients" written by young-hoo kim, jang-won park, and jun-shik kim published by international orthopaedics (sicot) (2015) 39:403¿409 doi 10.1007/s00264-014-2520-x published online 16 september 2014 was reviewed.The article's purpose: "the purpose of this study was to investigate the clinical and radiographic results and complication rates after cementless total hip arthroplasty using an ultrashort femoral stem in highly active [university of california, los angeles (ucla) activity level above 8 points] obese and non-obese patients." data was compiled from 108 patients with 138 hips involved in obese group and 125 patients with 168 hips involved in non obese group with mean follow up of 7.4 years (obese group) and 7.5 years (non-obese group).Depuy products utilized: pinnacle cup, proxima stem, coc bearing surfaces - all depuy products in all hips.Adverse events for both groups: clicking or squeaking sound (no interventions), dvt (located in femoral and external iliac veins and treated with inferior vena cava umbrella), intraoperative undisplaced linear calcar fracture (treated with cerclage cable without sequelae), dislocation (treated with closed reduction and abduction brace for 3 months without reoccurrence).

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 ACETABULAR LINERS
• Type of Device: HIP ACETABULAR LINERS
• 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: 9297830
• MDR Text Key: 167135231
• Report Number: 1818910-2019-111722
• Device Sequence Number: 1
• Product Code: KWY
• 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

• Date FDA Received: 11/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP ACETABULAR LINER
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer 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