MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 9/10 ULTAMET 36MM HEADS +0; SMALL TAPER (9/10) FEMORAL HEADS : HIP METAL FEMORAL HEADS

Catalog Number 962711000

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

Patient Problems Foreign Body Reaction (1868); Osteolysis (2377); Not Applicable (3189)

Event Type  Injury  

Manufacturer Narrative

Product complaint # (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 via tha by using the cup (manufactured by kyocera, p/n: 121780050, lot#: 00996) with 2 screws (manufactured by kyocera, p/n: 556071j, lot#: 03890 and p/n: 556072j, lot#: 01834), the insert (p/n: 121887350), the end cap (p/n: 961226000), the centralizer (p/n: 961246000), the stem (p/n: 961315000), the head (p/n: 962711000), the cement restrictor (p/n: 546016000).It was confirmed that there was osteolysis at superior acetabular caused by armd, and inadequate acetabular cup position, screw breakage.Thus, the revision surgery was scheduled to be performed on (b)(6) 2019 by transplanting ilium and allogeneic bones to superior acetabulum, and using a kt plate, a cemented cup.Dr¿s view: there was a possibility of being attributed to metal on metal.Possible cause: deterioration over time.No further information is available.

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.A worldwide complaint database search found no other reported incident(s) against the provided product/lot combination(s) since release for distribution.Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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.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.

• Brand Name: 9/10 ULTAMET 36MM HEADS +0
• 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: 9395813
• MDR Text Key: 185220195
• Report Number: 1818910-2019-118999
• 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: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 11/04/2019

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 Catalogue Number: 962711000
• Device Lot Number: 3028877
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/04/2019
• Initial Date FDA Received: 12/02/2019
• Supplement Dates Manufacturer Received: 01/21/2020; 03/26/2020
• Supplement Dates FDA Received: 01/24/2020; 04/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: C-STEM CENTRALIZER; C-STEM PMMA END CAP; C-STEM SZ 2 HIGH OFFSET; CEMENT RESTRICTOR SIZE 4; PINNACLE-A SCREW 6.5X20; PINNACLE-A SCREW 6.5X25
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR