MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US S-ROM*SLEEVE PRX ZTT, 18D-LRG; S-ROM HIP SYSTEM : HIP FEMORAL SLEEVE

Model Number	55-0524
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Bone Fracture(s) (1870); Pain (1994); Injury (2348); Osteolysis (2377); No Code Available (3191)
Date of Event	11/16/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).Initial reporter occupation: lawyer.(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
Pcf and medical records received.After review of medical records patient was revised to addressed failed right hip arthroplasty, adverse local tissue response secondary to metal debris and trocanteric fracture.Prior to revision, the patient alleged pain and injury.Operative notes indicated upon entering the hip, there was obvious destructive lesion occurring.Upon entering the joint space under pressure was this metal stained fiber purulent exudate, a very thick granular type of tissue that was destructive in nature.There were peripheral osteolytic lesions.The acetabular component was well fixed also with the stem.There was some mild degree of trunnion where noted.Lab result for chromium was above 7.Doi: (b)(6) 2009.Dor: (b)(6) 2018, right hip.
Additional Manufacturer Narrative
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, a follow-up medwatch will be filed as appropriate.

• 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: 9681013
• Report Number: 1818910-2020-04208
• Device Sequence Number: 11463193
• Product Code: LPH
• UDI-Device Identifier: 10603295175292
• UDI-Public: 10603295175292
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K934412
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/21/2020

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: 03/31/2014
• Device Model Number: 55-0524
• Device Catalogue Number: 550524
• Device Lot Number: 2874432
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/21/2020
• Supplement Date Received by Manufacturer: 03/13/2020
• Initial Report FDA Received Date: 02/07/2020
• Supplement Report FDA Received Date: 03/18/2020
• 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: 67 YR