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

Catalog Number UNK HIP ACETABULAR LINER

Device Problems Fracture (1260); Noise, Audible (3273)

Patient Problem No Code Available (3191)

Event Date 01/18/2017

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, ""mid-term results of the biolox delta ceramic-on-ceramic total hip arthroplasty"" written by y.K.Lee, y.C.Ha, j-i.Yoo, w.L.Jo, k-c.Kim, and k.H.Koo and published by the bone and joint journal vol.99-b, no.6, june 2017 accepted by publisher 18 january 2017 was reviewed.The article's purpose was to report on a study of a delta ceramic thas to determine the rate of ceramic fracture, to characterize post-operative noise, and to evaluate the mid-term results and survivorship.The data was compiled from 252 patients (286 hips) with a follow duration mean of 66.5 months and average age of 49.7 years (144 men and 108 women).Depuy products utilized: pinnacle cup, corail stem, and coc bearings on all hips.The article captures generalized adverse events, 2 narrative descriptions with patient identifiers and additionally a table displaying 32 patients who experienced implant noise all captured in linked complaints.This complaint captures report of noise patient (b)(6) a (b)(6) years old male r tha reporting a crack noise.9 year(s) post implant when walking.He required revision surgery as it was discovered that his ceramic liner was fractured and he received a new poly liner and ceramic head.

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, 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 ; 1210 ward avenue; west chester, PA 19380-0988 ; 6103142063
• MDR Report Key: 9260084
• MDR Text Key: 183374090
• Report Number: 1818910-2019-110629
• 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: 10/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2019
• 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: 01/07/2020
• 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
• Patient Age: 45 YR