MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SROM*STXXL,36+8LNK,24X19X325R; S-ROM HIP SYSTEM : HIP FEMORAL STEM

Catalog Number 563164R

Device Problem Loss of Osseointegration (2408)

Patient Problems Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Pain (1994); Swelling (2091); Inadequate Osseointegration (2646); No Code Available (3191)

Event Date 09/29/2017

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).

Event Description

Removed foreign body reaction patient harm.

Manufacturer Narrative

(b)(4).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

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 heen able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy as not 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.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: 9780072
• MDR Text Key: 184928242
• Report Number: 1818910-2020-06655
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/01/2020

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2013
• Device Catalogue Number: 563164R
• Device Lot Number: 2571581
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR