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

Catalog Number UNK HIP ACETABULAR CUP

Device Problems Loss of Osseointegration (2408); Osseointegration Problem (3003)

Patient Problems Pain (1994); No Code Available (3191)

Event Date 10/06/2019

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 ¿survival of monoblock rm vitamys compared with modular pinnacle cups: mid-term outcomes of 200 hips performed by a single surgeon¿, written by eustathios kenanidis, et al, published 6 october 2019 in hip international, was reviewed.The purpose of the article was to compare the mid-term survivorship of the rm pressfit vitamys monoblock cup with the well-documented modular pressfit pinncle cup as a reference.The authors¿ hypothesis was that the monoblock cup would improve mid-term survival compared to the modular uncemented design.Depuy products used: pinnacle cup, corail stem 200 cases were enrolled in the study, 93 patients received the pinnacle cup and 107 received the competitor cup.There was a mean follow-up of 57 months.Adverse events: there was one case of acute deep infection in otherwise stable and well-aligned prostheses in the pinnacle group that was diagnosed at 48 months postoperatively following a uti in a (b)(6) female patient.It was managed with 2-stage revision and an interval of intravenous antibiotics for two weeks followed by oral antibiotics for three months before final re-implantation.There was one case of aseptic loosening in the pinnacle group.The cup was well implanted in a (b)(6) male with a bmi over 40 and height over 180 cm.The patient suffered pain in the groin for a year before undergoing revision of both the acetabular and femoral component.The implants were removed with evidence of poor osseointegration attributed to poor compliance with weight bearing and activity recommendations.There were two hips who showed heterotopic ossification brooker class i at the one-year-follow-up.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the 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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

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.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.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 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: 9964272
• MDR Text Key: 188341523
• Report Number: 1818910-2020-10821
• 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,Followup
• Report Date: 04/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2020
• 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
• Date Manufacturer Received: 05/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention