MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SROM*STM ST,36+8L NK,18X13X160; S-ROM HIP SYSTEM : HIP FEMORAL STEM

Model Number 52-3418

Device Problem Osseointegration Problem (3003)

Patient Problem Inadequate Osseointegration (2646)

Event Date 09/14/2021

Event Type  Injury  

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

The patient was revised to address loosening of the femoral stem and sleeve at the implant to bone interface.The surgeon revised the stem, sleeve and head to the reclaim system.Upon trialing the 75 body, the screw that attaches to the stem broke into three pieces.All of those pieces were retrieved.Roughly 2 minutes of additional time was required to secure the broken trial body.Doi: (b)(6) 2020.Dor: (b)(6) 2021, left hip.

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 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 : a device history record (mre) review, was not possible because the required lot code was not provided.

• 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: 12546884
• MDR Text Key: 273782392
• Report Number: 1818910-2021-21375
• Device Sequence Number: 1
• Product Code: LWJ
• UDI-Device Identifier: 10603295171034
• UDI-Public: 10603295171034
• Combination Product (y/n): N
• PMA/PMN Number: P070026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 09/14/2021

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 52-3418
• Device Catalogue Number: 523418
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/14/2021
• Initial Date FDA Received: 09/29/2021
• Supplement Dates Manufacturer Received: 10/26/2021
• Supplement Dates FDA Received: 10/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DELTA CER HEAD 11/13 36MM +0; S-ROM*SLEEVE PRX ZTT, 18D-LRG; SROM*STM ST, 36+8L NK,18X13X160; DELTA CER HEAD 11/13 36MM +0; S-ROM*SLEEVE PRX ZTT, 18D-LRG; SROM*STM ST, 36+8L NK,18X13X160
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR