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

Catalog Number UNK HIP ACETABULAR CUP

Device Problems Naturally Worn (2988); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Unspecified Infection (1930); Pain (1994); Discomfort (2330); Impaired Healing (2378); No Code Available (3191)

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.

Event Description

On 30-may-2019 literature article entitled: charnley low-friction arthroplasty in teenage patients.The ultimate challenge.¿ the purpose of this study was to present the results of the use of the cemented charnley low friction arthroplasty and c-stems in patients under the age of 20 years who underwent total hip replacements between 1969 and 2001.A standard, ultra-high-molecular-weight polyethylene (uhmwpe) acetabular component 43 mm in diameter was used in 11 hips, a small component 40 mm in diameter in 14 and an offset bore 32 mm in diameter in 14.18 a standard charnley stem was used in five hips, of 3/4 neck length and congenital dislocation of the hip type stem or narrow stems in 24 hips.In ten hips a c-stem19 was more suitable because of the greater range of size.A head of 22.225 mm in diameter was used in all cases.In seven hips a zirconia ceramic head in combination with a c-stem was used.In three hips hylamer uhmwpe acetabular components were used in combination with a zirconia ceramic head.The study identified the following adverse outcomes: 9 patients experienced loose acetabular component.5 patients experienced loose femoral component.1 patient experienced gross wear of the acetabular component.1 patient experienced periprosthetic fracture of the femur.1 patient experienced infection.1 patient experienced delayed wound healing.7 patients experienced pain and discomfort.13 patients underwent a surgical intervention / revision.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.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.Device history lot: null.Device history batch: null.Device history review: null.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 CUP
• Type of Device: HIP ACETABULAR CUP
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 8709601
• MDR Text Key: 148406362
• Report Number: 1818910-2019-96237
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Type of Report: Initial,Followup
• Report Date: 05/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP ACETABULAR CUP
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention