MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SROM*STM ST,36+8L NK,18X13X160; S-ROM HIP SYSTEM : HIP FEMORAL STEM

Catalog Number 523418

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

Patient Problems Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Inflammation (1932); Pain (1994); Pocket Erosion (2013); Swelling (2091); Tissue Damage (2104); Limited Mobility Of The Implanted Joint (2671); Test Result (2695)

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

Litigation papers allege that the patient has suffered pain, swelling, lack of mobility, damage to surrounding tissue and bone caused by inflammation, metallosis, pseudotumours, bursitis, and bone erosion.Doi: (b)(6) 2002 - dor: none reported (left hip).Patient is a resident of (b)(6).Update ad 23 may 2018: wpc (b)(4) has been reopened under pc-(b)(4) due to receipt of ppf and implant record.There were no new allegations reported.Updated part and lot numbers of the impacted products.Added patient dob.Doi: (b)(6) 2002 -dor: none reported (left 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 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.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, 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: 9150667
• MDR Text Key: 161048679
• Report Number: 1818910-2019-107452
• Device Sequence Number: 1
• Product Code: JDI
• 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: other
• Type of Report: Initial,Followup
• Report Date: 09/18/2012

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 Catalogue Number: 523418
• Device Lot Number: 1006352
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/12/2019
• Initial Date FDA Received: 10/03/2019
• Supplement Dates Manufacturer Received: 10/11/2019
• Supplement Dates FDA Received: 10/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention