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

Catalog Number UNK HIP ACETABULAR CUP

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

Patient Problem Death (1802)

Event Type  Death  

Manufacturer Narrative

Product complaint # (b)(4).Report source is a literature article.There is limited information regarding the reported death.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, ¿review of total hip replacement.The middlemore hospital experience, 1980-1991¿ by pc poon, et al, published by new zealand medical journal (2001), vol.114, pp.254-256, was reviewed.The purpose of this article was to determine the outcome of 1951 thas performed at middlemore hospital between 1980-1991.The authors include charnley thas and 8 different competitor thas.Charnley became a depuy product in 1990.The total number of depuy products associated with the events listed within this article are unknown.Implanted depuy products: cemented charnley polyethylene cup, unknown femoral head, and cemented and cementless charnley femoral stem.The manufacturer of the cement was unknown.Results: the authors do not identify the date, nor do they specify component manufacturer in the following events.The number of depuy products associated with the following results is unknown.3 deaths attributed to postoperative pulmonary embolisms.26 postoperative deaths were reported.No cause for these deaths was identified.There is insufficient information to attribute these deaths to depuy products or surgical procedures.18 deep vein thrombi- treatment unspecified.9 pulmonary emboli- treatment unknown.15 nerve palsies- treatment and outcomes unknown.49 dislocations- 16 treated with revision of unknown components.65 wound infections-7 treated with implant excision.22 revisions for deep infection.2 fractures of charnley stems-treated with revision.5 unspecified periprosthetic fractures treated with revision.112 revisions for loosening of unspecified components.There is insufficient information provided to attribute the loosening to the charnley cups and stems that were cemented with unknown cement.10 patients reported severe postoperative pain that interfered with adls and walking.22 patients were bedridden or had extreme difficulty with mobility.Captured in the complaint: charnley cup: implant dislocation.Femoral head: implant dislocation.Charnley stem: implant loosening-implant to bone, implant fracture post-op.Patient harms: pain, medical device site joint range of motion decrease, fracture, inadequate osseointegration, deep vein thrombosis, pulmonary embolism, infection, would infection, surgical intervention, joint dislocation, nerve injury.Charnley stem, cup, and head: death.".

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.The complaint shall be closed with an undetermined conclusion; entered into the complaints database and monitored through trend analysis.Post market surveillance is per (b)(4).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 46581 0988
• MDR Report Key: 9417731
• MDR Text Key: 169285266
• Report Number: 1818910-2019-120890
• 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,health professional,l
• Type of Report: Initial,Followup
• Report Date: 11/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP ACETABULAR CUP
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death