MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US DUR BANTAM 10D 22.225X40 LINER; DURALOC IMPLANT : HIP POLY ACETABULAR LINERS

Model Number	1241-40-526
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Cyst(s) (1800); Granuloma (1876); No Code Available (3191)
Date of Event	11/15/2019
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
Change of duraloc pe inlay right side.Doi: 2004, inlay was revised in 2012, date of latest inlay revision (b)(6) 2019 because of pe wear.A surgical delay was not reported.
Additional Manufacturer Narrative
Product complaint # (b)(4).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. .
Additional 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.H10 additional narrative: corrected:h6- no code available is to capture surgical intervention.Product complaint # (b)(4).Investigation summary: examination of the returned liner confirms the reported material wear.Nothing unusual or unexpected about the amount of wear is identified.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.Depuy considers the investigation closed.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 will be filed as appropriate.

• Brand Name: DUR BANTAM 10D 22.225X40 LINER
• Common Device Name: DURALOC IMPLANT : HIP POLY ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9458373
• Report Number: 1818910-2019-122705
• Device Sequence Number: 11535860
• Product Code: LPH
• UDI-Device Identifier: 10603295018926
• UDI-Public: 10603295018926
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: foreign,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 1241-40-526
• Device Catalogue Number: 124140526
• Device Lot Number: 113574
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2020
• Initial Date Received by Manufacturer: 11/21/2019
• Supplement Date Received by Manufacturer: 01/03/2020; 01/30/2020
• Initial Report FDA Received Date: 12/12/2019
• Supplement Report FDA Received Date: 01/14/2020; 02/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 53 YR
• Patient Weight: 55