MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SUMMIT POR TAPER SZ4 HI OFF; SUMMIT HIP STEM : HIP FEMORAL STEM

Model Number 1570-11-100

Device Problem Degraded (1153)

Patient Problems Edema (1820); Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Pain (1994); Injury (2348); Test Result (2695); No Code Available (3191)

Event Date 12/19/2018

Event Type  Injury  

Manufacturer Narrative

(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

It was reported that the patient was feeling pain in his right hip caused by a mom liner.The metal head and metal liner were removed in the total hip revision procedure.Update december 13, 2019.After review of medical records, the patient was revised to address pain, metallosis, pseudotumor, elevated cobalt and chromium levels.Intraoperatively, there was a large amount of brownish yellowish fluid, a large pseudotumor, a fair amount of black corrosion on the trunnion and bone damage near the cup.Cup and stem were not loose and so were not revised.Doi: (b)(6) 2008.Dor: (b)(6) 2018; right hip.

Manufacturer Narrative

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 : the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

• Brand Name: SUMMIT POR TAPER SZ4 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: 9856985
• MDR Text Key: 188793389
• Report Number: 1818910-2020-08695
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 10603295060055
• UDI-Public: 10603295060055
• Combination Product (y/n): N
• PMA/PMN Number: K001991
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 12/19/2018

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 1570-11-100
• Device Catalogue Number: 157011100
• Device Lot Number: C5SDJ1000
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/04/2020
• Initial Date FDA Received: 03/19/2020
• Supplement Dates Manufacturer Received: 03/12/2021
• Supplement Dates FDA Received: 03/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CUP 121722050/C68E41000; HEAD 136553000/2518085; LINER 121887350/2759872; SCREW 121720500/C5FJ44000; SCREW 121730500/C5EP54000
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR