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

Catalog Number	961315000
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	10/03/2018
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
The inserter and the stem stuck together.
Additional 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 or Problem Description
Surgical delay 30 mins.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: examination of the returned instrument confirmed the complaint.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will 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.

• Brand Name: C-STEM SZ 2 HIGH OFFSET
• Common Device Name: C-STEM HIP IMPLANT : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD. 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• MDR Report Key: 7994739
• Report Number: 1818910-2018-73199
• Device Sequence Number: 288745
• Product Code: JDI
• UDI-Device Identifier: 10603295236849
• UDI-Public: 10603295236849
• Combination Product (Y/N): N
• PMA/510(K) Number: K003421
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 961315000
• Device Lot Number: D18050844
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2018
• Initial Date Received by Manufacturer: 10/03/2018
• Supplement Date Received by Manufacturer: 10/29/2018; 11/08/2018
• Initial Report FDA Received Date: 10/23/2018
• Supplement Report FDA Received Date: 10/31/2018; 11/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1