MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US S-ROM*SLEEVE PRX ZTT, 16D-SML; S-ROM HIP SYSTEM : HIP FEMORAL SLEEVE

Model Number	55-0513
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Pain (1994); Swelling (2091); Distress (2329); Discomfort (2330); Depression (2361); Ambulation or Postural Difficulties (2544); Inadequate Osseointegration (2646); No Code Available (3191)
Date of Event	03/01/2005
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.(b)(4).Initial reporter occupation: attorney.
Event or Problem Description
Litigation alleges the patient suffers from pain, discomfort, and dislocation.Even though the patient received a poly liner, the litigation is for metal on metal, so we are reporting the head and liner only.Update ad 03 may 2018 receipt of ppf and sticker sheets record.In addition to what were previously alleged, ppf alleges loosening of stem.
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.
Event or Problem Description
Pfs alleges post traumatic stress disorder, depression, swelling in both legs, limping, intense strain to the muscles, ligaments and tendons area, and use of cane for mobility.After review of medical records, it was confirmed that the patient was revised due to aseptic loosening of the left femoral component resulting to pain.Operative note reported femoral sleeve was loose with no bony ingrowth.There's no signs of infection and dislocation in the revision note.Bone scan reported increased activity at the femoral sleeve suggestive of loosening.
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.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.Device history lot : null.Device history batch : null.Device history review : null.

• Common Device Name: S-ROM HIP SYSTEM : HIP FEMORAL SLEEVE
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 8398625
• Report Number: 1818910-2019-86657
• Device Sequence Number: 13910263
• Product Code: LPH
• UDI-Device Identifier: 10603295175230
• UDI-Public: 10603295175230
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K934412
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2001
• Device Explanted Year: 2005
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/21/2019

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 55-0513
• Device Catalogue Number: 550513
• Device Lot Number: 640871
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/21/2019
• Supplement Date Received by Manufacturer: 07/15/2019; 04/07/2020
• Initial Report FDA Received Date: 03/07/2019
• Supplement Report FDA Received Date: 07/16/2019; 04/16/2020
• 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: 44 YR
• Patient Weight: 88