MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 S-ROM*SLEEVE PRX ZTT, 14B-SML; S-ROM HIP SYSTEM : HIP FEMORAL SLEEVE

Catalog Number 550501

Device Problem Connection Problem (2900)

Patient Problems Pain (1994); Tissue Damage (2104); Injury (2348); Ambulation Difficulties (2544)

Event Date 09/22/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Patient claim received.Patient's sister called on patient's behalf requesting compensation due to a broken hip implant.Patient's date of revision is unknown at this time, we do not have part/lot information, and we cannot assume which products are affecting the patient.Therefore, at this time we will report an unknown hip.We will update the complaint accordingly, should we receive additional information.Update 10/12/2016 product has been received and photo is attached.There is no new information that would change the existing mdr decision.Complaint was updated 10/13/2016.Updated 11/07/2016 notification of xrays received.There is not new information that would change the existing mdr decision.Compliant was updated 11/22/2016.Update ¿11/08/2016, 11/15/2016 medical records received.After review of the medical records for mdr reportability, in addition to what was previously reported the discharge notes report that the patient fell and suffered injury to the implant.The revision surgery notes reported a metal fatigue fracture of the right srom stem, and metallosis.During the procedure the surgeon reported that while attempting to remove the stem a fracture of the femur occurred and cables were placed.Adding head/liner.The complaint was updated on: 11/29/2016.Update rec'd 2/3/2017: part/lot for femoral head and liner is being updated.A correct dor was provided.This complaint was updated on: 2/3/2017.Update rec'd 04/13/2017: notification of explant being returned to patient was received.Update apr 25, 2017.Emailed received from paralegal.The explant is being returned to the patient.This was updated on apr 25, 2017.Doi: (b)(6) 2007; dor: (b)(6) 2015; right hip.Update 2/3/2017: dor: (b)(6) 2015.Update (b)(6) 30 may 2018: email received.Please re-open (b)(4).This hip complaint came in with the attune knee files.

Manufacturer Narrative

Pc-(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

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 Description

Information has been reviewed and determined that (b)(4) is a duplicate of (b)(4).Updates from (b)(4) are being transferred to (b)(4).Medical records 26jul2018 reviewed on 08apr2019: primary procedure notes not provided.It is referenced that the patient received bilateral total hip replacements in 2004 due to congenital hip dysplasia.Records reveal the patient sustained a fall, experienced pain and inability to ambulate.Revision operative notes 09/22/2015 indicate the patient received a right total hip revision due to metal fatigue fracture of the srom stem.Pre-op xrays revealed the fracture to be right above the ingrowth sleeve.Procedure notes indicate, upon entering the hip joint, pericapsular metallosis was encountered.Poly liner was removed due to wear.Surgical delay of multiple hours due to difficult prosthesis removal is indicated.The records indicate the metal sleeve and stem would not separate and appeared to be welded together, the surgeon suggests that perhaps the metal deformation from the fractured stem may have contributed to the difficulty with disengaging.Quite a bit of bone loss from the removal process is also documented.A spiral femoral bone fracture was sustained during the extraction process by impacting a femoral retrograde rod into the distal femur.Treatment for this includes cerclage wires, lateral buttress plate and 3 bicortical screws.Surgical delay of multiple hours due to difficult prosthesis removal is indicated.Quite a bit of bone loss from the removal process is also documented.Upon review of the records, the femoral retrograde rod is a synthes trauma product.The complaint involving synthes trauma implants has been captured in their complaint database under (b)(4) in their respective complaints database.

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.

• Type of Device: S-ROM HIP SYSTEM : HIP FEMORAL SLEEVE
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7691069
• MDR Text Key: 114078748
• Report Number: 1818910-2018-64498
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: K934412
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 550501
• Device Lot Number: 2126652
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/31/2021
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 36 YR
• Patient Weight: 72