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

Model Number	55-0514
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	05/09/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (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
This pc is related to (b)(4).The event reported in this pc occurred after the 3rd revision surgery performed on (b)(6) 2022.This patient underwent the initial surgery on (b)(6) 2015.The 1st revision surgery due to loosening of implants was performed on (b)(6) 2021.The 2nd revision surgery due to infection was performed on (b)(6) 2021, with a cement spacer containing antibiotics.The 3rd revision surgery via tha was performed on (b)(6) 2022.After the 3rd revision surgery, the 4th revision surgery due to infection was performed on (b)(6) 2022.In the 4th revision surgery, the surgeon implanted a new stem, head, liner after curettage and debridement were done.Zimmer biomet¿s product on acetabular and our company¿s sleeve were kept using as they were.The 4th revision surgery was completed successfully with no surgical delay.The surgeon commented that the cause of the infection was unknown.No further information is available.
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.Device history lot : the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

• 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: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 14487754
• Report Number: 1818910-2022-09529
• Device Sequence Number: 4808530
• Product Code: LPH
• UDI-Device Identifier: 10603295175247
• UDI-Public: 10603295175247
• 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: 2022
• Device Explanted Year: 2022
• 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,Followup
• Report Date (Section B): 05/24/2022

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 Model Number: 55-0514
• Device Catalogue Number: 550514
• Device Lot Number: 9763616
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/09/2022
• Supplement Date Received by Manufacturer: 06/02/2022
• Initial Report FDA Received Date: 05/24/2022
• Supplement Report FDA Received Date: 06/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/08/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: DELTA CER HEAD 9/10 28MM -3; S-ROM*SLEEVE PRX ZTT, 16D-LRG; SROM 9/10 16X11X130 30+4
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR
• Patient Sex: Female