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

Catalog Number UNK HIP FEMORAL STEM

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pulmonary Embolism (1498); Unspecified Infection (1930); Pain (1994); No Code Available (3191)

Event Date 07/09/2007

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.

Event Description

The literature article entitled, "the use of a posterior lip augmentation device for a revision of recurrent dislocation after primary cemented charnley/charnley elite total hip replacement" written by j.Mcconway, s.O'brien, e.Doran, p.Archbold, and d.Beverland published by the journal of bone and joint surgery accepted by publisher after revision on 9 july 2007 was reviewed.The article provides illustrative examples of the plad in figure 1 and figure 2.The article's purpose: "to evaluate retrospectively the clinical and radiological outcome associated with the use of a posterior lip augmentation device as a salvage treatment for instability and also to establish the complications associated with its use." data was compiled from 307 patients receiving plads in conjunction with the original depuy components that were experiencing recurrent dislocations.Cement manufacturer is unknown and screws utilized to fixate plads are assumed to be depuy.Original depuy implants: charnley/charnley elite cemented components with cemented poly cup depuy implants applied to original: plad with 5 screws adverse events: recurrent dislocations of original implants (treated by revision surgery with implantation of plad) prolonged rehab requiring extended hospitalization pulmonary embolism (no information regarding treatment provided) deep infection (treated by antibiotics, washout, and/or revision) further dislocation (treated by revision associated with plad broken screws) plad device migration (note of broken screws and treated by revision) loose cup noted that radiolucent line was present before insertion of plad which "increased afterwards" (treated by revision) pain (treated by revision) broken screws radiographically detected (no treatment provided).

• Brand Name: UNKNOWN HIP FEMORAL STEM
• Type of Device: HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic drive; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 9681135
• MDR Text Key: 185331705
• Report Number: 1818910-2020-04215
• Device Sequence Number: 1
• Product Code: KWY
• 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: 02/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP FEMORAL STEM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/03/2020
• Initial Date FDA Received: 02/07/2020
• Supplement Dates Manufacturer Received: 02/24/2020
• Supplement Dates FDA 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