MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 C-STEM SZ 2 HIGH OFFSET; C-STEM HIP IMPLANT : HIP FEMORAL STEM

Model Number 9613-15-000

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

Patient Problems Unspecified Infection (1930); Pain (1994); Not Applicable (3189); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary
=
> the head, metal liner and a small bone screw were returned for investigation.The products had been implanted for 11 years prior to revision which would suggest that no product defect was the cause.No information received with this individual complaint indicated that a broader investigation or corrective action was necessary.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.If information is obtained that was not available for the initial 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) 2009 via tha.It was reported that the removal surgery was performed by explanting the cup (manufactured by kyocera, p/n: 121780056, lot#: 00277), the liner (p/n: 121887356), the head (p/n: 962712000) due to suspected infection caused by pain, and indwelled cement spacer molds (date of surgery was unknown).The stem (p/n: 961315000) was retained at this time, and the revision surgery was scheduled to be performed about 3 months later by explanting the stem and implanting implants after confirming sedation of infection (date of surgery was not fixed yet).The stem is planning to be returned after the revision surgery has been performed.No further information is available.

• Brand Name: C-STEM SZ 2 HIGH OFFSET
• Type of Device: C-STEM HIP IMPLANT : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• Manufacturer (Section G): DEPUY INT'L LTD. 8010379; st anthonys road; leeds LS11 8 DT; UK LS11 8 DT
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 9686836
• MDR Text Key: 184374201
• Report Number: 1818910-2020-04346
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 10603295236849
• UDI-Public: 10603295236849
• Combination Product (y/n): N
• PMA/PMN Number: K003421
• 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: 01/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9613-15-000
• Device Catalogue Number: 961315000
• Device Lot Number: 2923974
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/23/2020
• Initial Date FDA Received: 02/10/2020
• Supplement Dates Manufacturer Received: 03/11/2020
• Supplement Dates FDA Received: 03/17/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/25/2009
• 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