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

Model Number	52-1465
Medical Device Problem Codes	Difficult to Remove (1528); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Unspecified Tissue Injury (4559)
Date of Event	10/12/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).This pc is related to (b)(4) which reports about the first revision surgery on (b)(6) 2015, treating loosening of implants after the primary tha surgery and (b)(4) which reports about the cold welding and not being able to disassemble the stem from the sleeve in the first revision surgery.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 reports about the event occurred in the second revision surgery on (b)(6) 2021.Loosening of implants occurred after the primary tha surgery and the first revision surgery was performed.After the first revision surgery, infection occurred, and the second revision surgery was performed on (b)(6) 2021.In the second revision surgery, the surgeon tried to disassemble the stem from the sleeve to remove them, but he couldn¿t.The surgeon unavoidably reamed the bone around the stem with a chisel and removed the stem and the sleeve integrated by using a slide hammer.Then, an implant (zimmer biomet¿s product) on the acetabular side was removed, and after careful cleaning, a cement spacer containing antibiotics was placed in the joint space.The second revision surgery was completed with 60 minutes delay.Because the stem and sleeve could not be separated at the time of removal, the damage to the femur increased.In the future, the third revision will be performed if possible while monitoring the patient's course.The surgeon wants us to identify the cause of the failure to separate the stem from the sleeve.No further information is available.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: the device associated with this report was received for examination.Physical examination confirmed the complaint.However, it is not possible to confirm a depuy's product failure as well as a relation between the adverse event and the reported product.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.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.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : the device associated with this report was received for examination.Physical examination confirmed the complaint.However, it is not possible to confirm a depuy's product failure as well as a relation between the adverse event and the reported product.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.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: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 12699390
• Report Number: 1818910-2021-23575
• Device Sequence Number: 11873180
• Product Code: LPH
• UDI-Device Identifier: 10603295170624
• UDI-Public: 10603295170624
• 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: 2015
• 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,Followup,Followup,Followup,Followup
• Report Date (Section B): 10/12/2021

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: 52-1465
• Device Catalogue Number: 521465
• Device Lot Number: 8018457
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/12/2021
• Supplement Date Received by Manufacturer: 11/09/2021; 01/04/2022; 05/11/2022; 08/18/2022
• Initial Report FDA Received Date: 10/26/2021
• Supplement Report FDA Received Date: 11/22/2021; 01/06/2022; 05/18/2022; 08/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/10/2014
• 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: 9/10 ULTAMET 36MM HEADS +3; COMPETITOR; S-ROM*SLEEVE PRX ZTT, 16B-LRG; SROM 9/10 16X11X130 30; UNKNOWN HIP ACETABULAR CUP; UNKNOWN HIP ACETABULAR CUP - COMPETITOR; UNKNOWN HIP ACETABULAR LINER; UNKNOWN HIP ACETABULAR LINER - COMPETITOR
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR
• Patient Sex: Female
• Patient Weight: 68 KG