MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SROM*STM STD,36NK,20X15X165; S-ROM HIP SYSTEM : HIP FEMORAL STEM

Model Number 52-3194

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

Patient Problems Edema (1820); Pain (1994); Joint Disorder (2373); Test Result (2695); No Code Available (3191)

Event Date 02/15/2016

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Initial reporter occupation: lawyer.(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

Reason for original complaint: litigation alleges that the patient suffered significant and chronic pain.Update ad 31 dec 2019: (b)(4) has been re-opened under (b)(4) due to medical records received.After review of medical records the patient was revised to address painful prosthesis due to elevated metal levels.Operative note reported having some impingement issue, capsule had brownish grayish metallic stained fluid and pseudocapsule was present.Doi: (b)(6) 2008.Dor: (b)(6) 2016, (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.H10 additional narrative: corrected: h6 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 - null.Device history batch - null.Device history review - null.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• 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: 9590606
• MDR Text Key: 175058525
• Report Number: 1818910-2020-01833
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 10603295170884
• UDI-Public: 10603295170884
• Combination Product (y/n): N
• PMA/PMN Number: K851422
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 08/27/2012

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2012
• Device Model Number: 52-3194
• Device Catalogue Number: 523194
• Device Lot Number: 2507936
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR