MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US S-ROM M HEAD 36MM +0; S-ROM FEMORAL HEADS (11/13) : HIP METAL FEMORAL HEADS

Catalog Number 136531000

Device Problems Naturally Worn (2988); Insufficient Information (3190)

Patient Problems Host-Tissue Reaction (1297); Pain (1994); Distress (2329); Discomfort (2330); Injury (2348); Deformity/ Disfigurement (2360); Not Applicable (3189)

Event Date 04/25/2017

Event Type  Injury  

Manufacturer Narrative

(b)().Initial reporter is an attorney.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 records received.Litigation alleges pain, discomfort, disfigurement, injury and distress.Doi: (b)(6) 2008; dor: (b)(6) 2017; right hip.

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

(b)(4).

Event Description

In addition to what previously alleged, ppf alleges metal wear, metallosis and elevated metal ions.Doi: (b)(6) 2008, dor: (b)(6) 2017, (left hip).

• Brand Name: S-ROM M HEAD 36MM +0
• Type of Device: S-ROM FEMORAL HEADS (11/13) : HIP METAL FEMORAL HEADS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 7000 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer (Section G): LEEDS MFG & MATERIAL WAREHOUSE; st anthonys road; leeds IN ; UK
• Manufacturer Contact: kara ditty-bovard ; 7000 orthopaedic drive; warsaw, IN 46582-0988 ; 6103142063
• MDR Report Key: 7882284
• MDR Text Key: 120453833
• Report Number: 1818910-2018-69556
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120599
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 08/22/2018

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: 04/30/2013
• Device Catalogue Number: 136531000
• Device Lot Number: 2613593
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/22/2018
• Initial Date FDA Received: 09/17/2018
• Supplement Dates Manufacturer Received: 09/25/2018; 02/04/2019
• Supplement Dates FDA Received: 09/26/2018; 02/05/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/30/2008
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 52 YR