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

Model Number 1570-11-120

Device Problems Corroded (1131); Degraded (1153)

Patient Problems Edema (1820); Foreign Body Reaction (1868); Pain (1994); Obstruction/Occlusion (2422); Test Result (2695); No Code Available (3191)

Event Date 12/07/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Initial reporter occupation: lawyer.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Pfs alleges cataracts, intussusception and macular degeneration.Pfs indicates that the allegations of cataracts, macular degeneration, intussusception and daily diarrhea in 2 hours of death as noted by the doctor from blockage possible from the metal hip.After review of medical records, the patient was revised to address pain, infection, metal reaction to cobalt and chrome, elevated metal ion levels.X-ray result indicates that the cup is possibly retroverted.This was confirmed during the surgery.Mri shows thickening of the capsule and effusion.The patient was found to have gross metallosis of the hip, a large amount of nonviable caseous tissue, thickening of the synovium, trunnionosis on the trunnion and on the inner surface of the cobalt chrome head.There was approximately 8 cc of cloudy tan fluid sent for testing.Doi: (b)(6) 2007; dor: (b)(6) 2018 (left hip).

Manufacturer Narrative

H10 additional narrative: corrected: h6 (closure codes and device codes).Product complaint #
=
> pc-(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
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> null.Device history review
=
> null.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

H10 additional narrative: product complaint #
=
> pc-000667032 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 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: 9865969
• MDR Text Key: 184483739
• Report Number: 1818910-2020-08850
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 10603295060079
• UDI-Public: 10603295060079
• 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
• Report Date: 03/04/2020

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2016
• Device Model Number: 1570-11-120
• Device Catalogue Number: 157011120
• Device Lot Number: A4WAW1000
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/04/2020
• Initial Date FDA Received: 03/23/2020
• Supplement Dates Manufacturer Received: 04/21/2020; 04/21/2020
• Supplement Dates FDA Received: 04/21/2020; 04/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR
• Patient Weight: 97