MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 UNKNOWN HIP ACETABULAR CUP

Catalog Number UNK HIP ACETABULAR CUP

Device Problem Loss of or Failure to Bond (1068)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

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

A literature article was received, entitled: "the cemented acetabular component of a total hip replacement - all polyethylene versus metal backing", by merrill a.Ritter, md, published in clinical orthopaedics and related research, number 311, pp 69-75.Following review by clinician, the author demonstrated that a cemented all-polyethylene acetabular cup component had better survivability versus a cemented metal-backed polyethylene acetabular component.Failure was defined as either cup loosening or revision surgery with a minimum follow-up period of one year.From 1969-1983, author performed 238 depuy charnley total hip replacements, 141 depuy mueller total hip replacements, and 659 competitor system total hip replacements.The charnley hips were cemented hips utilizing all-poly cups with 22 mm femoral heads and stainless steel stems.The mueller hips were cemented hips using all-poly cups with 32 mm cobalt-chrome heads and stems.It was noted that one hundred of the competitor products formed the group of metal backed acetabular components.No other product specific information, such as catalog or lot numbers was provided, nor were specific patient events identified.The author indicated that of the 238 charnley cups, 32 failed: 21 were noted as loose (interface unspecified), and an additional 11 were actually part of a revision surgery (reasons unspecified for the revision).Of the 141 mueller cups, 29 failed: 23 were noted as loose (interface unspecified), and an additional 6 were part of a revision surgery (reasons unspecified for the 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 associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot number was not provided.Based on previous investigations, this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.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 will be filed as appropriate.

• Brand Name: UNKNOWN HIP ACETABULAR CUP
• Type of Device: HIP ACETABULAR CUP
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 8755238
• MDR Text Key: 152080366
• Report Number: 1818910-2019-97572
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Type of Report: Initial,Followup
• Report Date: 06/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2019
• Is this an Adverse Event Report?: No
• 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: 07/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1