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

Catalog Number UNK HIP ACETABULAR CUP

Device Problems Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)

Patient Problems Bone Fracture(s) (1870); Unspecified Infection (1930); No Code Available (3191)

Event Date 06/24/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).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.(b)(4).

Event Description

"literature article entitled, ¿comparable results with porous metal augments in combination with either cemented or uncemented cups in revision hip arthroplasty: an analysis of one hundred forty-seven revisions at a mean of five years¿ by ahmed nageeb mahmoud, md, ms orth, et al, published by the journal of arthroplasty (2017), vol.32, pp.1612-1617.The purpose of this study was to retrospectively review and compare the clinical and radiographic outcomes of porous metal augments in cemented and uncemented acetabular revisions between november 2006 and june 2015.The study included products from depuy and competitor manufacturers.Depuy products: 5 charnley marathon polyethylene cups, 13 pinnacle gription acetabular augments.Femoral components were not included in this study.The cement used foe the cup was a competitor product.The products explanted during revision are unknown.Results: the authors provide a table with patients and results, however, there is insufficient information to identify which components were implanted.This complaint will capture the total results for cemented cups.Results: 1 revision of cup and augment for chronic periprosthetic infection 3 cup revisions for aseptic loosening.There is insufficient evidence to attribute the loosening to the cup cemented with competitor cement.1 acetabular periprosthetic fracture treated with orif.Captured in this complaint: charnley marathon polyethylene cup and pinnacle gription acetabular augment.".

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 ACETABULAR CUP
• Type of Device: HIP ACETABULAR CUP
• 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 ; 6103142063
• MDR Report Key: 9344245
• MDR Text Key: 183190981
• Report Number: 1818910-2019-115150
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: SW
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP ACETABULAR CUP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/11/2019
• 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