MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 ELITE PLUS OGEE CUP 28/47; MISCELLANEOUS HIP CUP/LINER : HIP POLY ACETABULAR CUPS

Model Number	9653-28-047
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); No Code Available (3191)
Date of Event	03/16/2020
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.
Event or Problem Description
The primary surgery was performed on (b)(6) 2013 via tha.It was reported that there was an indication of infection for several years, and the surgeon had administered antibiotic to the patient and followed infection¿s progress.However, on (b)(6) 2020, the removal surgery was performed.The surgeon removed the cup (p/n: 965328047), the head (p/n: 962734000), the c-stem (p/n: 961315000), the centralizer (p/n: 961246000), the end cap (p/n: 961226000) and the cement restrictor (p/n: 546014000) and placed a cement space molds.The surgery was completed, and it was unknown whether there was a surgical delay or not.No further information is available.
Additional 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 associated with this report was received for examination.A worldwide complaint database search found no other reported incident(s) against the provided product/lot combination(s) since release for distribution.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.Corrective action was not indicated.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: ELITE PLUS OGEE CUP 28/47
• Common Device Name: MISCELLANEOUS HIP CUP/LINER : HIP POLY ACETABULAR CUPS
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• MDR Report Key: 9900798
• Report Number: 1818910-2020-09646
• Device Sequence Number: 2827957
• Product Code: JDI
• UDI-Device Identifier: 10603295318835
• UDI-Public: 10603295318835
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K871867
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/15/2020

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: 9653-28-047
• Device Catalogue Number: 965328047
• Device Lot Number: 3596566
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/15/2020
• Supplement Date Received by Manufacturer: 04/23/2020
• Initial Report FDA Received Date: 03/30/2020
• Supplement Report FDA Received Date: 04/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: C-STEM CENTRALIZER; C-STEM PMMA END CAP; C-STEM SZ 2 HIGH OFFSET; CEMENT RESTRICTOR SIZE 3; ELITE MODULAR HD 28MM +3; ELITE PLUS OGEE CUP 28/47
• Outcome Attributed to Adverse Event: Required Intervention