MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 9/10 ULTAMET 28MM HEADS +3; SMALL TAPER (9/10) FEMORAL HEADS : HIP METAL FEMORAL HEADS

Catalog Number 962702100

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Foreign Body Reaction (1868); Pain (1994); Not Applicable (3189); No Code Available (3191)

Event Date 12/23/2019

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).

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

The primary surgery was performed via metal-on-metal tha of the patient¿s right hip joint (date of surgery was unknown).It was reported that the patient felt a pain after 10 years from the primary surgery, it was confirmed there was loosening, and the revision surgery was performed on (b)(6) 2019 by washing out thoroughly at trunnion which was discolored black, and replacing the cup (manufactured by kyocera, p/n: 121781050, lot#: unknown), the liner (p/n: 121889150), the head (p/n: 962702100), the hole eliminator (p/n: 124603000) due to pain, suspected an acetabular cup loosening, trunnionosis.The surrounding soft tissue was clean.A stem was retained, and a gription sector cup 54mm with 2 screws, a hole eliminator, a marathon face-changing poly liner 54 mm+4 10°, an elite metal head 32 mm+3 were implanted.The surgery was completed outside a 30 minutes surgical delay.No further information is available.

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.H10 additional narrative: corrected:h6.Added:d10,h3.Product complaint # (b)(4).Investigation summary: the device was reviewed by bioengineering and report was received stating: it was unlikely that a manufacturing defect was present root cause undetermined.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may 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: 9/10 ULTAMET 28MM HEADS +3
• Type of Device: SMALL TAPER (9/10) FEMORAL HEADS : HIP METAL FEMORAL HEADS
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• MDR Report Key: 9577093
• MDR Text Key: 185637931
• Report Number: 1818910-2020-01483
• Device Sequence Number: 1
• Product Code: KXA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 962702100
• Device Lot Number: 2543600
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2020
• Date Manufacturer Received: 02/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention