MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SROM*STM ST,30+4L NK,16X11X150; S-ROM HIP SYSTEM : HIP FEMORAL STEM

Model Number 56-3516

Device Problem Use of Device Problem (1670)

Patient Problems Cyst(s) (1800); Pain (1994); Synovitis (2094); Joint Laxity (4526); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 03/09/2021

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

On (b)(6) 2000, the patient had a right press-fit arthroplasty to address pain, discomfort and stiffness secondary to osteoarthritits/labral calcification.Depuy components, including srom stem/sleeve were used during this procedure.Two screws were placed.Medical records from (b)(6) 2021 note the patient has been experiencing right hip instability.On (b)(6) 2021, the patient had a revision right total hip to address failed right total hip arthroplasty, secondary to eccentric polywear with polyethylene synovitis and recurrent subluxation.Depuy components were used during this procedure.The indications for surgery included pain and ¿probably has some impingement with secondary poly wear.¿ the surgeon reported finding eccentric polywear, with synovitis.The stem and cup had less than optimal anteversion and were revised.A cyst was noted in the iliopsoas tendon sheath and was debrided.Depuy components were implanted during this procedure.Date of implantation: (b)(6) 2000, date of revision: (b)(6) 2021, (right hip).

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.Provided x-ray images have been reviewed.With regard to the femoral stem there is nothing indicative of a product problem identified.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 : there is no evidence to suggest product error in material or manufacturing was a factor in the need for revision surgery after more than 20 years implanted.A manufacturing records review (mre) will not be performed even when lot code is known.

• Type of Device: S-ROM HIP SYSTEM : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 11676051
• MDR Text Key: 245774656
• Report Number: 1818910-2021-08061
• Device Sequence Number: 1
• Product Code: LWJ
• UDI-Device Identifier: 10603295178194
• UDI-Public: 10603295178194
• Combination Product (y/n): N
• PMA/PMN Number: P070026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,study
• Type of Report: Initial,Followup
• Report Date: 03/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 56-3516
• Device Catalogue Number: 563516
• Device Lot Number: 692959
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DRLC FINISHED SECTOR 50MM; DUR MAR NEUT 50ODX28ID; S-ROM*HEAD FEMORAL COCR 28+0; SROM*STM ST,30+4L NK,16X11X150; UNK HIP BONE SCREW; UNK HIP BONE SCREW; UNK HIP FEMORAL SLEEVE SROM; UNK HIP LOCKING RING; DRLC FINISHED SECTOR 50MM; DUR MAR NEUT 50ODX28ID; S-ROM*HEAD FEMORAL COCR 28+0; SROM*STM ST,30+4L NK,16X11X150; UNK HIP BONE SCREW; UNK HIP BONE SCREW; UNK HIP FEMORAL SLEEVE SROM; UNK HIP LOCKING RING
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR
• Patient Weight: 91