MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 5.0MM DIA TPRD HD PER SCRW 40; BONE SCREWS AND PINS : SCREWS

Catalog Number	125740000
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Osseointegration Problem (3003)
Health Effect - Clinical Codes	Inflammation (1932); Pain (1994); Discomfort (2330); Inadequate Osseointegration (2646)
Date of Event	12/04/2014
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).Occupation: attorney.Surgical intervention.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
Patient alleges pain, discomfort, inflammation, popping and snapping and elevated metal ion levels, pseudotumor, loosening of cup, metal wear metallosis, and elevated metal ions.Doi: (b)(6) 2009 - dor: (b)(6) 2014 (right hip).
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.H10 additional narrative: corrected: h6(device code).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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 5.0MM DIA TPRD HD PER SCRW 40
• Common Device Name: BONE SCREWS AND PINS : SCREWS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 8070815
• Report Number: 1818910-2018-75500
• Device Sequence Number: 1658138
• Product Code: JDI
• UDI-Device Identifier: 10603295019893
• UDI-Public: 10603295019893
• Combination Product (Y/N): N
• PMA/510(K) Number: MM 38-07
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/24/2018

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 Catalogue Number: 125740000
• Device Lot Number: DC5HC4000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/24/2018
• Supplement Date Received by Manufacturer: 09/23/2019
• Initial Report FDA Received Date: 11/14/2018
• Supplement Report FDA Received Date: 10/22/2019
• 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: 35 YR
• Patient Weight: 111