MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US S-ROM*SLEEVE PRX ZTT, 20F-SML; S-ROM HIP SYSTEM : HIP FEMORAL SLEEVE

Model Number	55-0535
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Edema (1820); Fever (1858); Foreign Body Reaction (1868); Hemorrhage/Blood Loss/Bleeding (1888); Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930); Inflammation (1932); Necrosis (1971); Pain (1994); Seroma (2069); Tissue Damage (2104); Discomfort (2330); Hypoesthesia (2352); Osteolysis (2377); Limited Mobility Of The Implanted Joint (2671); Test Result (2695)
Date of Event	06/03/2011
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Occupation: lawyer.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.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.
Event or Problem Description
New ecm record created in order to update legacy complaint (b)(4).New etq record created in order to update etq (legacy system) complaint number (b)(4).Reason for original complaint litigation papers allege: patient was implanted with a depuy asr hip on (b)(6) 2009.Patient experienced pain, inhibition of the ability to walk, unnecessary and additional surgery, and other injuries presently undiagnosed.Patient has been and/or will be forced to undergo a revision surgery.Doi: (b)(6) 2009 - dor: n/i.Patient is a resident of (b)(6).Update (b)(6) 2012 - plaintiff¿s preliminary disclosure form was received, which identified (part/lot) information.The complaint and associated mdrs were updated.There was no new information that would change the outcome of the investigation.Update (b)(6) 2013 - plaintiff¿s preliminary disclosure form was received with medical documents, which identified dob, doi, dor, side information.The complaint and associated mdrs were updated.There was no new information that would change the outcome of the investigation.Doi: (b)(6) 2009 - dor: (b)(6) 2012 (left hip).Update ad (b)(6) 2019.(b)(4) has been reopened under (b)(4) due to receipt of pfs and medical records.Pfs alleges pain while walking and bending over, inability to do day to day activities, pseudotumors, fluid in the joint, metallosis and necrosis.Medical records report pain, bleeding from the operative side, seroma, sanguineous drainage, fall, stiffness, osteolysis, swelling, soreness, numbness, fever, inability to walk or sit, mild tenderness to palpation of the hip, loosening of the acetabular component, wound dehiscence, poor wound healing, implant noise, seroma and avulsion of the abductor medius.Patient had multiple complications leading to multiple surgical interventions: debridement of wound and placement of rectus femoris muscle flap (b)(6) 2010, incision and drainage on (b)(6) 2009, irrigation and debridement with application of wound vac on (b)(6) 2009, debridement on (b)(6) 2009.Surgical pathology reports significant acute inflammation.Left hip aspiration on (b)(6) 2012 indicates approximately 6 cc of brown, purulent fluid.The patient was then revised to address an infected left hip on (b)(6) 2012.The hip was described as having gross purulence, a large amount of synovitic response and a very thickened pseudo capsule.The asr cup was noted to have 0% bony ingrowth.Doi: (b)(6) 2009 - dor: (b)(6) 2012 (left hip).

• 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: 9928086
• Report Number: 1818910-2020-10023
• Device Sequence Number: 11467678
• Product Code: LPH
• UDI-Device Identifier: 10603295175353
• UDI-Public: 10603295175353
• 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: 2009
• Device Explanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/03/2011

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: No Information
• Device Model Number: 55-0535
• Device Catalogue Number: 550535
• Device Lot Number: 2909816
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/16/2020
• Initial Report FDA Received Date: 04/06/2020
• 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: 66 YR
• Patient Weight: 85