MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SROM*STM ST,30+4L NK,16X11X150; S-ROM HIP SYSTEM : HIP FEMORAL STEM

Model Number	56-3516
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Osseointegration Problem (3003)
Health Effect - Clinical Codes	Inadequate Osseointegration (2646); No Code Available (3191)
Date of Event	09/09/2011
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.Attorney.(b)(4).
Event or Problem Description
Patient was revised to address dislocation.Update 10/25/2012- litigation papers received.There is no new additional information that would affect the investigation.Update ad 15 may 2018: the receipt of ppf and sticker sheets received.In addition to what was previously alleged, ppf alleges loosening of cup, fracture (component), dislocation with open reduction, and loosening of stem.It was indicated in the revision sticker sheets that the cup and liner were removed on (b)(6) 2011.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: corrected: h6 (device).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: S-ROM HIP SYSTEM : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 8073394
• Report Number: 1818910-2018-75589
• Device Sequence Number: 1616314
• Product Code: JDI
• UDI-Device Identifier: 10603295178194
• UDI-Public: 10603295178194
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K851422
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/23/2018

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: 07/26/2012
• Device Model Number: 56-3516
• Device Catalogue Number: 563516
• Device Lot Number: 2424922
• Initial Date Received by Manufacturer: 10/23/2018
• Supplement Date Received by Manufacturer: 02/03/2020
• Initial Report FDA Received Date: 11/15/2018
• Supplement Report FDA Received Date: 02/17/2020
• 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: 62 YR
• Patient Weight: 104