MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US 5.0MM DIA TPRD HD PER SCRW 25; BONE SCREWS AND PINS : SCREWS

Catalog Number	125725000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Inflammation (1932); Pain (1994); Discomfort (2330); No Code Available (3191)
Date of Event	02/19/2009
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).Initial reporter occupation: attorney.
Event or Problem Description
Litigation alleges that the patient suffers from pain, discomfort, inflammation, popping/snapping, and large amounts of toxic cobalt chromium metal ions and particles.Update ad 09 may 2018: (b)(4) has been re-opened under (b)(4) due to the receipt of ppf and sticker sheets.In addition to what were previously alleged, ppf alleges infection.
Additional Manufacturer Narrative
Product complaint # (b)(4).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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.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.No device(s) associated with this report was received for examination.In order to determine if a lot related issue was possible, a worldwide complaint database search was performed.A complaint database search did find additional results but no related reports against the provided product code and lot number combination(s).Based on the inability to find any additional related reports against the provided product code/lot code combination it is reasonable to conclude that there are no anomalies with regard to manufacturing or inspection contained in the device history records that would contribute to the reported event.The reported event is considered one of the possible complications of joint replacement.Investigational inputs were requested as indicated per internal procedures for this failure mode.The complaint information provided has been reviewed for complaint coding, medical device reporting, and other data required by the complaint system.Follow-up for additional event information, if applicable, was conducted utilizing work instruction (b)(4) appendix a.Without the physical complaint sample(s) associated with this report, it was not possible to determine if the device(s) failed to meet specification(s) at the time it was released for distribution.The device(s) associated with this event were used in the treatment of the patient as prescribed by the presiding surgeon.From the event information received, it was not possible to determine the relationship of the device to the reported event.No information received with this individual complaint indicated that a broader investigation or corrective action was necessary.Device history lot : null.Device history batch : null.Device history review : null.

• Brand Name: 5.0MM DIA TPRD HD PER SCRW 25
• Common Device Name: BONE SCREWS AND PINS : SCREWS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 8212187
• Report Number: 1818910-2019-79725
• Device Sequence Number: 13957252
• Product Code: JDI
• UDI-Device Identifier: 10603295019862
• UDI-Public: 10603295019862
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K861979
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2006
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/10/2018

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: 125725000
• Device Lot Number: YV2B74000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/10/2018
• Supplement Date Received by Manufacturer: 09/26/2019
• Initial Report FDA Received Date: 01/03/2019
• Supplement Report FDA Received Date: 10/25/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 35 YR
• Patient Weight: 91