MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 9/10 ULTAMET 36MM HEADS +3; SMALL TAPER (9/10) FEMORAL HEADS : HIP METAL FEMORAL HEADS

Catalog Number 962712000

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Foreign Body Reaction (1868); Pain (1994); Joint Dislocation (2374); No Code Available (3191)

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

The primary surgery was performed on (b)(6) 2010 by mom via tha.It was reported that the revision surgery was performed on (b)(6) 2020 by replacing the head (p/n: 962712000), the insert (p/n: 121887350), the stem (p/n: 961102500) and a cup ((b)(6) product, p/n: 121780050) because the patient had a pain and a suspicion of a dislocation due to the loosening of the implants.The surgery was completed, and it was unknown whether there was any surgical delay.We got investigation request for the cause of the loosening of the implants, a trunnions and other corrosion.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.Product complaint # (b)(4).Investigation summary : the head, liner and stem products were returned for investigation.A worldwide complaint database search found a previous complaint (b)(4) and a device history record review found no anomalies.No product defects were noted.Corrective action was not indicated.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Product complaint # (b)(4).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.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 36MM 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: 9943897
• MDR Text Key: 187858074
• Report Number: 1818910-2020-10573
• Device Sequence Number: 1
• Product Code: JDG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 03/23/2020

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 Catalogue Number: 962712000
• Device Lot Number: 3002229
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2020
• Initial Date Manufacturer Received: 03/23/2020
• Initial Date FDA Received: 04/09/2020
• Supplement Dates Manufacturer Received: 05/13/2020; 06/09/2020
• Supplement Dates FDA Received: 05/18/2020; 06/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 9/10 ULTAMET 36MM HEADS +3; C-STEM SIZE 3A; PINN-A MULTIHOLE ACET CUP 50MM; PINNACLE MTL INS NEUT36IDX50OD
• Patient Outcome(s): Required Intervention