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

Model Number	55-0523
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Hematoma (1884); Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930); Pain (1994); Tissue Damage (2104); No Code Available (3191)
Date of Event	07/06/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Initial reporter occupation: lawyer.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
After review of medical records, it was indicated that the patient complains of progressive pain and underwent a prior reported hematoma debridement for a suspected quadriceps tear.The patient presented with a pseudotumor and concern for metalosis from his metal on metal hip and was then revised for left total hip metal on metal wear with pseudotumor.Operative notes reported that there was a considerable amount of hematoma was identified.The abductors were attenuated but not grossly compromised.The femoral head was removed and trunnionosis was noted.Intraoperative pathology documented positive frozen specimens, which was present in the tissue sent at the beginning of the case.Pathology report not provided.Doi: (b)(6) 2007; dor: (b)(6) 2017; left hip.
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: 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: 9865679
• Report Number: 1818910-2020-08830
• Device Sequence Number: 16871521
• Product Code: LPH
• UDI-Device Identifier: 10603295175285
• UDI-Public: 10603295175285
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K934412
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/01/2020

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: 01/31/2012
• Device Model Number: 55-0523
• Device Catalogue Number: 550523
• Device Lot Number: 2294931
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/01/2020
• Supplement Date Received by Manufacturer: 04/28/2020
• Initial Report FDA Received Date: 03/23/2020
• Supplement Report FDA Received Date: 04/30/2020
• 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: 69 YR