MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 S-ROM*STM STD,36NK,18X13X160; S-ROM HIP SYSTEM : HIP FEMORAL STEM

Catalog Number 523193

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problems Host-Tissue Reaction (1297); Pain (1994); Swelling (2091); Discomfort (2330); Joint Swelling (2356)

Event Date 04/22/2014

Event Type  Injury  

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Complete product detail has not been received at this time.If further information is received a follow-up medwatch will be filed as appropriate.

Event Description

Litigation alleges the patient suffers from pain, discomfort and toxic cobalt-chromium metal ions and particles to be released into the blood, tissue and bone.Update (b)(6) 2017: pfs received.Pfs also alleges dislocation, masses in the right hip, swelling, and felt like popping.This complaints is updated on (b)(6) 2017.

Manufacturer Narrative

Product complaint: 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.

Manufacturer Narrative

Depuy synthese is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on 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: the device associated with this report was not returned for examination.Depuy synthese considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may 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.

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.Udi: (b)(4).

Event Description

Ppf alleges metallosis.Added revision hospital, surgeon, lawyer and law firm.Updated product details based on implant records.Removed metal poisoning on the stem.Added swelling to all ip and also added blood heavy metal increased to head and liner which was not capture on the previous report.Corrected event date on pc and dor on all ips.

• Type of Device: S-ROM HIP SYSTEM : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7052050
• MDR Text Key: 92719479
• Report Number: 1818910-2017-29624
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• PMA/PMN Number: K851422
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/27/2017

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: 523193
• Device Lot Number: 3334287
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/27/2017
• Initial Date FDA Received: 11/22/2017
• Supplement Dates Manufacturer Received: 05/15/2018; 02/12/2019; 10/11/2019
• Supplement Dates FDA Received: 05/18/2018; 02/21/2019; 10/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 51 YR
• Patient Weight: 56