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

Model Number 1521-90-059

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

Patient Problems Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Pain (1994); Not Applicable (3189); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

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, a follow-up medwatch will be filed as appropriate.

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) 2013 via tha.It was confirmed that there was like tumor on the lateral side of femur recently, and although the patient was under observation, the patient had started to complain of pain.Thus, the revision surgery was performed on (b)(6) 2020 by replacing the stem (p/n: unknown), the head (p/n: unknown), the liner (p/n: unknown), the hole eliminator (p/n: unknown).It was judged that it was armd because the stem-neck junction had been discolored to black.The hip joint was filled with pseudotumor and it was scraped as much as possible.The tumor on the lateral side of femur was disappeared by scraping the pseudotumor.There was a possibility of the pseudotumor had been pushed from inside of the joint to the lateral part of the femur.The surgery was completed within a 30 minutes surgical delay.No further information is available.

• Brand Name: 9/10 COCR HEAD 28MM +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
• Manufacturer (Section G): JJMSZ PLANT FOR STK. & N-STK.; no. 299, changyang street; suzhou industrial park; suzhou, jiangsu 21512 6; CH 215126
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 9711972
• MDR Text Key: 184731026
• Report Number: 1818910-2020-04905
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 10603295276647
• UDI-Public: 10603295276647
• Combination Product (y/n): N
• PMA/PMN Number: K871867
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/29/2020

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?: No
• Device Operator: Health Professional
• Device Model Number: 1521-90-059
• Device Catalogue Number: 152190059
• Device Lot Number: D12090295
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/29/2020
• Initial Date FDA Received: 02/14/2020
• Supplement Dates Manufacturer Received: 03/11/2020
• Supplement Dates FDA Received: 03/12/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/20/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR