MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN HIP IMPLANT

Catalog Number UNK HIP

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

Patient Problems Unspecified Infection (1930); Nerve Damage (1979); Not Applicable (3189); No Code Available (3191)

Event Date 01/01/2003

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, "acetabular revision without cement" written by tze-pui ng, mbchb, frcse (ortho), fhkam (ortho surg) and kwong-yuen chiu, mbbs, fhkam (ortho surg) published by the journal of arthroplasty vol.18 no.4 2003 was reviewed.The article's purpose is "to evaluate the results of cementless acetabular revision with hemispherical porous-coated cups." data was compiled from 47 acetabular revisions (19 men and 21 women with average age performed between 1993 to 1997.The article does not identify the original implants with the exception of charnley stems (both old and newer models).The article indicates that metal hip balls were utilized in conjunction with the poly inserts during revision surgery so it is reasonable to assume all components were depuy.Depuy products utilized: duraloc cup, poly liner, metal head, screws (in cases of bone inadequacies for cup fixation) adverse events: dislocations treated by revision, closed reduction and/or conservative management 1 dislocation attributed to cup mispositioning treated with revision (radiographic image figure 1) nerve palsies post revision self recovered infections by revision and or excision arthroplasty.

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 IMPLANT
• Type of Device: HIP IMPLANT
• 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: 9575128
• MDR Text Key: 185784006
• Report Number: 1818910-2020-01448
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: HK
• 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: 01/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/14/2020
• 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