MAUDE Adverse Event Report: DEPUY ORTHOPAEDIC INC, 1818910 SROM*STM ST,30+4L NK,16X11X150; S-ROM HIP SYSTEM : HIP FEMORAL STEM

Catalog Number	563516
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Pain (1994); Swelling (2091); Discomfort (2330); Inadequate Osseointegration (2646)
Date of Event	02/06/2012
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.
Event or Problem Description
New etq record created in order to update etq (legacy system) complaint number wpc (b)(4).Reason for original complaint.- patient was revised to address loosening of the srom sleeve.Doi: (b)(6) 2006 - dor: (b)(6) 2012 (right hip).Update - (b)(6) 2012 - litigation papers received.They allege that the patient suffers from severe pain, discomfort, swelling, and difficulty sleeping.An invoice was located and the part/lot information was added for the metal liner and femoral head.Initial emdrs were created.Update - (b)(6) 2012 - plaintiff¿s preliminary disclosure form was received, which identified the patient's name, "(b)(6)".The complaint and associated mdrs were updated.There was no new information that would change the outcome of the investigation.Update: (b)(6) 2012 pfs was received from legal, medical records were received from legal.There is no new information that would change the existing mdr decision.Records are available for further review.Update ad (b)(6) 2018: (b)(4) has been re-opened under (b)(4) due to the receipt of ppf and medical records.In addition to what was previously alleged, ppf alleges loosening of stem.After review of medical records for the mdr reportability, patient was revised to address loosening femoral component.Added facility name, added revision hospital/account name.Added stem (b)(4), lot # 2016219.Doi: (b)(6) 2006 - dor: (b)(6) 2012 (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 ORTHOPAEDIC INC, 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7783028
• Report Number: 1818910-2018-66648
• Device Sequence Number: 2076556
• Product Code: JDI
• UDI-Device Identifier: 10603295178194
• UDI-Public: 10603295178194
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2006
• Device Explanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/20/2018

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: 563516
• Device Lot Number: 2016219
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/20/2018
• Supplement Date Received by Manufacturer: 08/27/2018
• Initial Report FDA Received Date: 08/14/2018
• Supplement Report FDA Received Date: 09/14/2018
• 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: 33 YR
• Patient Weight: 59