MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SUMMIT POR TAPER SZ6 HI OFF; SUMMIT HIP STEM : HIP FEMORAL STEM

Catalog Number 157011120

Device Problems Difficult to Remove (1528); Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191); Noise, Audible (3273)

Patient Problems Foreign Body Reaction (1868); Pain (1994); Loss of Range of Motion (2032); Synovitis (2094); Joint Swelling (2356); Not Applicable (3189); No Code Available (3191)

Event Date 10/24/2012

Event Type  malfunction  

Manufacturer Narrative

This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.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

Litigation alleges that the patient suffers from pain.Doi: (b)(6) 2008 - dor: none reported (unknown side) (right side (b)(6) 2015).Patient is a resident of (b)(6).Update 02/26/2013 - the complaint has been reopened because it has been reported that the patient was revised on (b)(6) 2013 to address squeaking, pain, and reduced range of motion.Part numbers were provided.Update: 3/24/2013 pfs was received from legal, medical records were received from legal, and part/lot information was identified.Records are available for further review.(right hip) update 11/25/15- pfs and medical records received.Pfs and medical records reviewed for mdr reportability.Pfs reported decreased range of motion, pain, and squeaking.Medical records and revision surgical report noted squeaking, popping, a fall on ice 2009 on right hip, metallosis, gray fluid, gray stained tissue, severe synovitis, anteverted acetabular component (this was not revised so not reported), difficulty liner removal, chronic effusion, increase metal ions but no lab reports were within records, and one proud screw that was removed.Stem added for high metal ions and the screw is being added for being proud.

Manufacturer Narrative

No device associated with this report was received for examination.A worldwide complaint database search found no other reported incident(s) against the provided product/lot combinations since release for distribution.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.Corrective action was not indicated.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.

Manufacturer Narrative

Event Description

Ppf alleges metal wear.Added surgeon and lawyer in the associated contact.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the 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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: SUMMIT POR TAPER SZ6 HI OFF
• Type of Device: SUMMIT HIP STEM : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 5299096
• MDR Text Key: 33558120
• Report Number: 1818910-2015-37536
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: K001991
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/24/2012

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: 07/08/2018
• Device Catalogue Number: 157011120
• Device Lot Number: CY5F1B000
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/25/2015
• Initial Date FDA Received: 12/15/2015
• Supplement Dates Manufacturer Received: Not provided; 09/25/2018; 12/10/2019
• Supplement Dates FDA Received: 02/01/2016; 09/26/2018; 01/08/2020
• 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: 93