MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US S-ROM*SCREW,6.5MM DIA,30MM LG; BONE SCREWS AND PINS : SCREWS

Catalog Number	556073
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Osteolysis (2377); Inadequate Osseointegration (2646)
Date of Event	11/09/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint #: (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).
Event or Problem Description
This revision hip was for revision of loose acetabular component.Osteolysis present in proximal.
Additional Manufacturer Narrative
Product complaint # (b)(4).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.Corrective action was not indicated.

• Common Device Name: BONE SCREWS AND PINS : SCREWS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 8137159
• Report Number: 1818910-2018-77327
• Device Sequence Number: 19238833
• Product Code: LPH
• UDI-Device Identifier: 10603295175933
• UDI-Public: 10603295175933
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K951000
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2001
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/09/2018

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: No Information
• Device Expiration Date: 01/31/2011
• Device Catalogue Number: 556073
• Device Lot Number: 251683
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/09/2018
• Supplement Date Received by Manufacturer: 02/07/2019
• Initial Report FDA Received Date: 12/06/2018
• Supplement Report FDA Received Date: 02/07/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 82 YR