MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 S-ROM M HEAD 36MM +3; S-ROM FEMORAL HEADS (11/13) : HIP METAL FEMORAL HEADS

Catalog Number 136532000

Device Problem Insufficient Information (3190)

Patient Problems Host-Tissue Reaction (1297); Inflammation (1932); Pain (1994); Loss of Range of Motion (2032); Distress (2329); Discomfort (2330); Injury (2348); Deformity/ Disfigurement (2360); Limited Mobility Of The Implanted Joint (2671); Test Result (2695); Not Applicable (3189)

Event Date 03/20/2017

Event Type  Injury  

Manufacturer Narrative

Product complaint # (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 litigation received.Litigation alleges friction and wear between the cobalt-chromium metal head and cobalt-chromium metal liner caused large amounts of toxic cobalt-chromium metal ions to be released in the blood resulting in injury, pain, discomfort, inflammation, emotional distress, loss of mobility, loss of range of motion, mental anguish, and disfigurement.Doi: (b)(6) 2006 - dor: (b)(6) 2017; left hip.

Manufacturer Narrative

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, 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).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.

Event Description

Pf alleges pseudotumor and metallosis.Pfs alleges metal toxicity feom elevated metal ions, tissue damage caused by metal debris, inflammation, pain, pseudotumor filled grayish pus and limited range of motion.After review of medical records, patient was revised to address adverse locat tissue reaction and pseudotumor.Revision notes stated that there was large amount of yellow fluid with fibrinous debris and metal staining.Clinic visits reported of leg length discripancy.Lab results for metal ions were above 7ppb.

• Brand Name: S-ROM M HEAD 36MM +3
• Type of Device: S-ROM FEMORAL HEADS (11/13) : HIP METAL FEMORAL HEADS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7855379
• MDR Text Key: 119531082
• Report Number: 1818910-2018-68730
• 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: other
• Type of Report: Initial,Followup,Followup
• Report Date: 08/13/2018

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 Expiration Date: 05/31/2011
• Device Catalogue Number: 136532000
• Device Lot Number: 2167753
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/13/2018
• Initial Date FDA Received: 09/07/2018
• Supplement Dates Manufacturer Received: 10/03/2018; 03/04/2019
• Supplement Dates FDA Received: 10/04/2018; 03/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR
• Patient Weight: 66