MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SROM STM STD 36+12L 13X18; S-ROM HIP SYSTEM : HIP FEMORAL STEM

Model Number 56-3618

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Edema (1820); Foreign Body Reaction (1868); Pain (1994); Osteolysis (2377); Limited Mobility Of The Implanted Joint (2671); Test Result (2695); No Code Available (3191)

Event Date 04/26/2017

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

After review of medical records, the patient was revised to address metallosis, pain, elevated metal ion levels and osteolysis.Intraoperatively, tan appearing synovial fluid consistent with metallosis was obtained.Discharge summary notes history of swelling and marked loss of function.Doi: (b)(6) 2009; dor: (b)(6) 2017 (left hip).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: SROM STM STD 36+12L 13X18
• 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: 9794638
• MDR Text Key: 187547191
• Report Number: 1818910-2020-07014
• Device Sequence Number: 1
• Product Code: MRA
• UDI-Device Identifier: 10603295178224
• UDI-Public: 10603295178224
• Combination Product (y/n): N
• PMA/PMN Number: P040023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 02/18/2020

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 Expiration Date: 05/31/2014
• Device Model Number: 56-3618
• Device Catalogue Number: 563618
• Device Lot Number: 2932974
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/18/2020
• Initial Date FDA Received: 03/05/2020
• Supplement Dates Manufacturer Received: 04/07/2020
• Supplement Dates FDA Received: 04/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CUP 121722058/DX8D41000; HEAD 136542500/2278502; HOLE ELIMINATOR 124603000/DY4JF1000; LINER 121887458/2866493; SCREW 121720500/DW7C24000; SCREW 121725500/DS2DS4000; SCREW 121750500/C39GA4000; SLEEVE 550524/2931507; STEM 563618/2932974
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR