MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SROM*STM ST,36+8L NK,20X15X165; S-ROM HIP SYSTEM : HIP FEMORAL STEM

Catalog Number 523420

Device Problems Biocompatibility (2886); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Loss of Range of Motion (2032); Swelling (2091); Tissue Damage (2104); Weakness (2145); Discomfort (2330); Osteolysis (2377); Limited Mobility Of The Implanted Joint (2671); Test Result (2695); No Code Available (3191)

Event Date 05/14/2014

Event Type  Injury  

Manufacturer Narrative

(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).

Event Description

Complaint description: litigation received.Litigation alleges metal debris and metallosis was found during revision.Update 6/8/2016- pfs and medical records received.Pfs and medical records reviewed for mdr reportability.Pfs reported severe pain, extensive metallosis, pseudotumor, limited mobility, continued pain after revision and daily use of cane.Medical records reported left hip hyperextension accident with anterior dislocation that was reduced ((b)(6) 2004), two falls ((b)(6) 2003), left leg weakness, left leg longer than right leg, discomfort with range of motion, left cup loose and vertical, bilateral lower extremity swelling with right greater than left, and osteolysis left side.Revision surgical report noted extensive osteolysis, apparent cup loosening, extensive metallosis, capsule and muscle with metal debris and staining.Cup added to complaint and part/lot updated the complaint was updated on: jun 22, 2016.Update ad 07 may 2018 receipt of ppf and implant records.In addition to what previously alleged, ppf alleges elevated metal ions before first revision.Added stem to address elevated metal ions.Updated product experience code.

Manufacturer Narrative

Depuy synthese is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the information which depuy synthese has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthese or its employees that the report constitutes an admission that the device, depuy synthese, 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: 8342768
• MDR Text Key: 136241158
• Report Number: 1818910-2019-84643
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 10603295171041
• UDI-Public: 10603295171041
• Combination Product (y/n): N
• PMA/PMN Number: K851422
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 02/04/2019

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: 523420
• Device Lot Number: 1016496
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/04/2019
• Initial Date FDA Received: 02/15/2019
• Supplement Dates Manufacturer Received: 11/16/2019
• Supplement Dates FDA Received: 11/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 77 YR
• Patient Weight: 73