MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US S-ROM M HEAD 36MM +0; HIP FEMORAL HEAD

Catalog Number 136531000

Device Problems Material Disintegration (1177); Naturally Worn (2988); Insufficient Information (3190); Appropriate Term/Code Not Available (3191)

Patient Problems Host-Tissue Reaction (1297); Foreign Body Reaction (1868); Muscular Rigidity (1968); Necrosis (1971); Pain (1994); Loss of Range of Motion (2032); Renal Failure (2041); Synovitis (2094); Tissue Damage (2104); Discomfort (2330); Cognitive Changes (2551); No Code Available (3191)

Event Date 09/11/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Patient was revised to address pain.It also stated that the surgeon saw very little black stained tissue.

Event Description

In addition to what was previously reported, litigation alleges discomfort, stiffness, loss of motion, elevated metal ions, implant loosening, metallosis, necrosis, soft tissue damage and muscle damage.Stem has been added due to alleged high metal ions.Added complainant information.

Manufacturer Narrative

No device associated with this report was received for examination.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

(b)(4).Depuy considers the investigation closed at this time.Should the 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

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

Manufacturer Narrative

Additional narrative: udi: (b)(4).

Event Description

In addition to what were previously alleged, ppf alleges metal wear.

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.

• Brand Name: S-ROM M HEAD 36MM +0
• Type of Device: HIP FEMORAL HEAD
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 6937640
• MDR Text Key: 88885831
• Report Number: 1818910-2017-26295
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 10603295033363
• UDI-Public: 10603295033363
• Combination Product (y/n): N
• PMA/PMN Number: K120599
• 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,Followup
• Report Date: 09/11/2017

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 Expiration Date: 04/24/2011
• Device Catalogue Number: 136531000
• Device Lot Number: 2153968
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/11/2017
• Initial Date FDA Received: 10/10/2017
• Supplement Dates Manufacturer Received: 11/20/2017; 11/21/2017; 01/08/2018; 07/23/2018; 10/16/2018; 11/28/2019
• Supplement Dates FDA Received: 11/20/2017; 12/04/2017; 01/25/2018; 08/20/2018; 10/16/2018; 12/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR
• Patient Weight: 77