MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US 5.0MM DIA TPRD HD PER SCRW 30; BONE SCREWS AND PINS : SCREWS

Catalog Number	125730000
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Codes	Unspecified Infection (1930); Pain (1994); Tissue Damage (2104); Inadequate Osseointegration (2646); Not Applicable (3189)
Date of Event	05/10/2012
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(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.Reporter is an attorney.
Event or Problem Description
Reason for original complaint.- patient was revised to address a painful leg.A little bit of corrosion was noticed inside the femoral head.Doi: (b)(6) 1998; (stem & sleeve); (b)(6) 2010; (head & liner); dor: (b)(6) 2012; (left hip).Update ad 25 april 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 pseudotumor, loosening of cup, infection and loosening of stem.Added bone screws due to alleged loosening of cup.Added lawyer and law firm.Doi: (b)(6) 2010; dor: (b)(6) 2012; (left hip).(b)(4).

• Brand Name: 5.0MM DIA TPRD HD PER SCRW 30
• 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: 7842014
• Report Number: 1818910-2018-68346
• Device Sequence Number: 16639562
• Product Code: JDI
• UDI-Device Identifier: 10603295019879
• UDI-Public: 10603295019879
• 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: 2010
• Device Explanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/09/2018

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: 125730000
• Device Lot Number: ET6KR4000
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/09/2018
• Initial Report FDA Received Date: 09/04/2018
• 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: 58 YR
• Patient Weight: 76