MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 UNKNOWN HIP FEMORAL HEAD

Catalog Number UNK HIP FEMORAL HEAD

Device Problem Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Device was used for treatment, not diagnosis.The quantity of specific products affected is unknown, as the literature article that this report refers to did not provide quantities.

Event Description

Literature received entitled, "recommendation for dealing with fractured ceramic insert and ceramic head fractures." by heller k.D., et.Al, written as an ae-recommended action, mar 15, 2017 (publishing source and author contact information was not provided).The authors reported that in germany, registry data and the data from ceramtec, a break occurs in 1 in 5,000 biolox delta inserts and 1 in 100,000 biolox delta ball heads.The cause of a ceramic insert break is a technical fault in 82% of cases (mostly inserts placed off-angle), in 3% of cases it is a positioning error or recurring subluxations.In 4% of cases, excess impact load within the framework of accidents or falls are the cause, while no cause can be found in 11% (per the ceramtec database).The article offered recommended best-practice treatment to address implant fractures of this nature.The article did not provide any specific cases or numbers of adverse events, beyond the noted percentages indicated above.No product or lot code information was provided for any product malfunctions/failures.This report will address the biolox delta ceramic liner and the biolox delta ceramic head.

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.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will 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 FEMORAL HEAD
• Type of Device: HIP FEMORAL HEAD
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910 ; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 8379513
• MDR Text Key: 137934132
• Report Number: 1818910-2019-86092
• Device Sequence Number: 1
• Product Code: KWY
• 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: 02/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP FEMORAL HEAD
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/28/2019
• Initial Date FDA Received: 02/28/2019
• Supplement Dates Manufacturer Received: 04/04/2019
• Supplement Dates FDA Received: 04/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1