MAUDE Adverse Event Report: DEPUY RAYNHAM ¿ 1219655 S-ROM*SCREW,6.5MM DIA,25MM LG; HIP OTHER IMPLANT

Catalog Number	556072
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Code	Foreign Body Reaction (1868)
Date of Event	05/30/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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
The patient was revised to address loose cup due to armd.
Additional Manufacturer Narrative
The patient was revised to address loose cup due to armd.No device associated with this report was received for examination.Depuy considers the investigation closed at this time.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: HIP OTHER IMPLANT
• Manufacturer (Section D): DEPUY RAYNHAM ¿ 1219655; 325 paramount drive; raynham MA 02767
• MDR Report Key: 6673225
• Report Number: 1818910-2017-20238
• Device Sequence Number: 1971139
• Product Code: LPH
• UDI-Device Identifier: 10603295175926
• UDI-Public: 10603295175926
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K951000
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/30/2017

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: 556072
• Device Lot Number: 337929R
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/30/2017
• Supplement Date Received by Manufacturer: 09/04/2017
• Initial Report FDA Received Date: 06/28/2017
• Supplement Report FDA Received Date: 09/04/2017
• 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: 81 YR