MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US 5.0MM DIA TPRD HD PER SCRW 50; BONE SCREWS AND PINS : SCREWS

Catalog Number	125750000
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Pain (1994); Tissue Damage (2104); Discomfort (2330); Inadequate Osseointegration (2646); No Code Available (3191)
Date of Event	06/20/2013
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).Occupation: attorney.
Event or Problem Description
Patient was revised to address pain.Litigation alleges discomfort and difficulty ambulating.Update ad (b)(6) 2018 receipt of ppf and implant records.In addition to what were previously alleged, ppf alleges loosening of cup, metal wear and elevated metal.Ions.
Additional Manufacturer Narrative
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.

• Brand Name: 5.0MM DIA TPRD HD PER SCRW 50
• 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: 8230809
• Report Number: 1818910-2019-80267
• Device Sequence Number: 11198940
• Product Code: JDI
• UDI-Device Identifier: 10603295019916
• UDI-Public: 10603295019916
• 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: 2009
• Device Explanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/14/2018

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: 125750000
• Device Lot Number: CN6A84000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/14/2018
• Supplement Date Received by Manufacturer: 01/19/2019
• Initial Report FDA Received Date: 01/09/2019
• Supplement Report FDA Received Date: 10/24/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR
• Patient Weight: 75