MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SROM*STM ST,36+8L NK,22X17X165; S-ROM HIP SYSTEM : HIP FEMORAL STEM

Catalog Number	523422
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Codes	Unspecified Infection (1930); Inadequate Osseointegration (2646); Not Applicable (3189)
Date of Event	07/18/2006
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.
Event or Problem Description
Pinnacle ppf and sticker sheets received.Ppf alleges infection requiring iv antibiotics and loosening of stem.It was also indicated in stickers sheets that pinnacle sector ii acetabular cup, pinnacle cancellous bone screw, s-rom total hip system femoral stem standard, and s-rom total hip system ztt proximal sleeve were implanted on (b)(6) 2006.Doi: (b)(6) 2006 - dor: (b)(6) 2010 (right hip).
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.

• Common Device Name: S-ROM HIP SYSTEM : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7689481
• Report Number: 1818910-2018-64437
• Device Sequence Number: 920251
• Product Code: JDI
• UDI-Device Identifier: 10603295171058
• UDI-Public: 10603295171058
• Combination Product (Y/N): N
• PMA/510(K) Number: K851422
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2006
• Device Explanted Year: 2010
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other Caregivers
• Type of Report: Initial,Followup
• Report Date (Section B): 06/21/2018

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: 523422
• Device Lot Number: 2050301
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/21/2018
• Supplement Date Received by Manufacturer: 11/10/2018
• Initial Report FDA Received Date: 07/16/2018
• Supplement Report FDA Received Date: 11/13/2018
• 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: 56 YR