MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US S-ROM*SLEEVE PRX ZTT, 14D-SML; S-ROM HIP SYSTEM : HIP FEMORAL SLEEVE

Model Number	55-0503
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930); Swelling/ Edema (4577)
Date of Event	11/16/2021
Type of Reportable Event	Malfunction
Event or Problem Description
This pc is related to (b)(4) which reports about the primary surgery via tka.This pc reports about the revision surgery was performed due to the accumulation of the water in pseudotumor excision site.After the removal surgery of pseudotumor performed in (b)(6) 2021, it was found that the accumulation of the water in pseudotumor excision site.The patient was suspected of having an infection, so the revision surgery was performed on (b)(6) 2021, and the implants were removed.The surgery was completed successfully within 30 minutes delay.No further information is available.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: the devices associated with this report was returned to j&j (b)(4) and were sent to a third party for a further evaluation.Examination of the returned devices found corrosion and signs of wear in the implants.The corroded surface showed residues of a mixture of biologically derived substances and metal corrosion subproducts.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may 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 SLEEVE
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 13558366
• Report Number: 1818910-2022-03072
• Device Sequence Number: 3734665
• Product Code: LPH
• UDI-Device Identifier: 10603295175193
• UDI-Public: 10603295175193
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P070026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/09/2009
• Device Model Number: 55-0503
• Device Catalogue Number: 550503
• Device Lot Number: 1184626
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/17/2022
• Initial Report FDA Received Date: 02/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/05/2005
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown