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

Catalog Number UNK HIP ACETABULAR CUP

Device Problems Device Dislodged or Dislocated (2923); Naturally Worn (2988)

Patient Problems Unspecified Infection (1930); Joint Dislocation (2374); Not Applicable (3189); No Code Available (3191)

Event Date 03/21/2017

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

"literature article entitled, ¿experience of the posterior lip augmentation device in a regional hip arthroplasty unit as a treatment for recurrent dislocation¿ by l.Hoggett, et al, published by journal of orthopaedics (2017), vol.14, pp.512-514, was reviewed.The purpose of this article is to review the authors¿ experience using the posterior lip augmentation device (plad) to treat recurrent dislocations implanted between january 2007 and november 2012 in 55 hips.Implanted depuy products: all patients had a charnley polyethylene cup paired with a charnley monoblock stem.The plad devices were secured with 5 screws.Dislocation occurred in all hips prior to implantation of the plad device.Results after plad insertion: there were 14 patients who required reoperations or revisions.8 reoperations for dislocations.Treatment included closed reduction, plad revision, acetabular revision, and/or conversion to a girdlestone.1 plad revision due to screw breakage.1 tha revision due to aseptic loosening of the stem.3 cases of infection treated with irrigation and debridement and/or tha revision surgery.Radiographic results: there were 26 cases of radiographically identified trochanteric fracture at the osteotomy site prior to plad insertion.Treatment was not specified.The authors do not specify if any of these events were associated with the revision surgeries noted in the article.There were 35 cases of radiographically identified polyethylene wear noted before plad insertion.11 cases were confirmed macroscopically during plad insertion surgery.Impacted products: charnley polyethylene cup: implant dislocation, implant bearing wear.Charnley monoblock stem: implant loosening/interface unknown, implant dislocation, fracture.Plad implant: no reported product problem.Plad screw: implant fracture/metal.Health impact: surgical intervention, device revision, and medical device removal.Symptoms: infection, joint dislocation".

• Brand Name: UNKNOWN HIP ACETABULAR CUP
• Type of Device: HIP ACETABULAR CUP
• 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: 9716373
• MDR Text Key: 185429679
• Report Number: 1818910-2020-04982
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 02/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP ACETABULAR CUP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/02/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention