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 Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Adhesion(s) (1695); Edema (1820); Foreign Body Reaction (1868); Inflammation (1932); Pain (1994); Limited Mobility Of The Implanted Joint (2671); Test Result (2695); Fibrosis (3167); No Code Available (3191)

Event Date 10/23/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Initial reporter occupation: lawyer.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 for an unknown reason.Patient originally had a metal on metal hip construct involving a pinnacle shell and an srom stem.The surgeon elected to exchange the head and liner.The metal on metal construct was removed and the hip was converted to a ceramic on polyethylene.Doi: (b)(6) 2008, dor: (b)(6) 2018, left hip.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.Although some device photographs were provided, none were of the femoral stem.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 material, manufacturing, inspection or sterile processing 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 STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9853434
• MDR Text Key: 184080705
• Report Number: 1818910-2020-08613
• Device Sequence Number: 1
• Product Code: LWJ
• UDI-Device Identifier: 10603295171034
• UDI-Public: 10603295171034
• Combination Product (y/n): N
• PMA/PMN Number: K851422
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 10/23/2018

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
• Device Operator: Health Professional
• Device Model Number: 52-3418
• Device Catalogue Number: 523418
• Device Lot Number: 2368893
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/25/2020
• Initial Date FDA Received: 03/19/2020
• Supplement Dates Manufacturer Received: 05/20/2021
• Supplement Dates FDA Received: 05/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR