MAUDE Adverse Event Report: DEPUY ORTHOPAEDIC INC, 1818910 5.0MM DIA TPRD HD PER SCRW 55; BONE SCREWS AND PINS : SCREWS

Catalog Number	125755000
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Pain (1994); Discomfort (2330); Inadequate Osseointegration (2646); Not Applicable (3189)
Date of Event	12/28/2009
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.
Event or Problem Description
Surgery, patient began suffering from pain and discomfort in his hip.Doi: (b)(6) 2007 - dor: (b)(6) 2009 (right hip).Update ad 26 apr 2018: (b)(4) has been reopened under (b)(4) due to receipt of ppf and sticker sheets.  in addition to what were previously alleged, ppf alleges loosening of the cup and fracture of a component.The stem was added to the impacted product as it was removed during the revision surgery.Part/lot numbers and patient information were provided in the ppf.Doi: (b)(6) 2007 - dor: (b)(6) 2009 (right hip).
Additional Manufacturer Narrative
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.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 55
• Common Device Name: BONE SCREWS AND PINS : SCREWS
• Manufacturer (Section D): DEPUY ORTHOPAEDIC INC, 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7866831
• Report Number: 1818910-2018-69033
• Device Sequence Number: 1719574
• Product Code: JDI
• UDI-Device Identifier: 10603295019923
• UDI-Public: 10603295019923
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K861979
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Device Explanted Year: 2009
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/16/2018

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: 125755000
• Device Lot Number: X52C44000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/16/2018
• Supplement Date Received by Manufacturer: 10/09/2018
• Initial Report FDA Received Date: 09/11/2018
• Supplement Report FDA Received Date: 10/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 52 YR