MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 S-ROM*SCREW,5.0MM DIA,45 MM LG; BONE SCREWS AND PINS : SCREWS

Catalog Number	521554
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Codes	Necrosis (1971); Scar Tissue (2060); Discomfort (2330); Osteolysis (2377); Not Applicable (3189)
Date of Event	09/01/2005
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.An attorney.
Event or Problem Description
Pfs and medical records received.Pfs alleges discomfort, asymmetric wear and instability.After review of medical records for the mdr reportability patient was revised due to failed acetabular component.Revision notes reported of large amount of scar tissue, osteolysis, 2 peripheral screws were removed, and found the cup to be loose.Clinical visits reported of loose acetabular cup, and osteolytic defect.Doi: (b)(6) 2004; dor: (b)(6) 2005; (left 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.

• 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: 7796972
• Report Number: 1818910-2018-67128
• Device Sequence Number: 2217959
• Product Code: LPH
• UDI-Device Identifier: 10603295170754
• UDI-Public: 10603295170754
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K951000
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2004
• Device Explanted Year: 2005
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/26/2018

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 Expiration Date: 05/03/2007
• Device Catalogue Number: 521554
• Device Lot Number: 294241
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/26/2018
• Supplement Date Received by Manufacturer: 11/26/2018
• Initial Report FDA Received Date: 08/20/2018
• Supplement Report FDA Received Date: 11/30/2018
• 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: 36 YR