MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US S-ROM M HEAD 36MM +9; S-ROM FEMORAL HEADS (11/13) : HIP METAL FEMORAL HEADS

Model Number 1365-34-000

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

Patient Problems Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Pain (1994); Swelling (2091); No Code Available (3191)

Event Date 09/29/2017

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Us fda mdr determination: there were no reported product problems with the retained cup.It is reasonable to attribute the reported patient harms to the loosening of the stem and sleeve and the pseudotumor attributed to the articulating surfaces.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

Pinnacle claim submission form and medical record received.After review of medical record, patient was revised to address failed right total hip replacement.Revision notes reported femoral component was grossly loose and was removed.Patient had marked deformity in femur.Liner was loosened.Head,liner, and stem were removed.Patient experienced pain, swelling,pseudotumor, had blood on the aspirate and possible metallosis.Doi: (b)(6) 2011.Dor: (b)(6) 2017, (right hip).

Manufacturer Narrative

Product complaint # (b)(4).

Event Description

Removed foreign body reaction patient harm.

Manufacturer Narrative

Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on 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.

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: S-ROM M HEAD 36MM +9
• Type of Device: S-ROM FEMORAL HEADS (11/13) : HIP METAL FEMORAL HEADS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9780066
• MDR Text Key: 181773109
• Report Number: 1818910-2020-06656
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 10603295033523
• UDI-Public: 10603295033523
• Combination Product (y/n): N
• PMA/PMN Number: K120599
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2014
• Device Model Number: 1365-34-000
• Device Catalogue Number: 136534000
• Device Lot Number: 2036971A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR