MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 TOTAL HIP BALL 28MM +0; LARGE TAPER FEMORAL HEADS : HIP METAL FEMORAL HEADS

Model Number	1018-11-000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Tissue Damage (2104); Osteolysis (2377); No Code Available (3191)
Date of Event	11/04/2008
Type of Reportable Event	Serious Injury
Additional 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.Concomitant medical products: duraloc 300 series 60mm od 124660000; hylamer neut 60 or 72odx28id, 125120025; unknown hip femoral stem.Initial reporter occupation: non-healthcare professional.
Event or Problem Description
Patient contacted depuy to report problems with implants.On (b)(6) 2010 the reason for revision surgery was determined.Upon receipt of medical records on 6/3/2010 it was confirmed that depuy products were implanted in the right hip at the original surgery on (b)(6) 1996.Patient was revised on (b)(6) 2008 to address acetabular loosening and osteolysis.Doi: (b)(6) 1996; dor: (b)(6) 2008; (right side).Update:litigation papers received.There is no new additional information that would affect the investigation.Update 08 jun 2018.Wpc (b)(4) has been re-opened under (b)(4) due to receipt of pinnacle ppf record.Litigation alleges metal wear and metallosis confirmed in medical records.Added manufacturing date and lawyer firm as well.
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:  added h6 h6 patient code: no code available (3191) used to capture surgical intervention patient code product complaint # (b)(4).Investigation summary - no device associated with this report was received for examination.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: TOTAL HIP BALL 28MM +0
• Common Device Name: LARGE TAPER FEMORAL HEADS : HIP METAL FEMORAL HEADS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 7747689
• Report Number: 1818910-2018-65699
• Device Sequence Number: 1084456
• Product Code: JDI
• UDI-Device Identifier: 10603295001324
• UDI-Public: 10603295001324
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K860701
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 1996
• Device Explanted Year: 2008
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/17/2020

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: 1018-11-000
• Device Catalogue Number: 101811000
• Device Lot Number: 769930038
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/06/2018
• Supplement Date Received by Manufacturer: 04/17/2020
• Initial Report FDA Received Date: 08/03/2018
• Supplement Report FDA Received Date: 04/28/2020
• 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: 48 YR