MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 RECLAIM DISTAL TAPERED 17X140; HIP FEMORAL STEM/SLEEVE

Catalog Number	197617140
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	07/23/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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
It was reported that the femur fractured and 4 control cables had to be used.
Additional Manufacturer Narrative
(b)(4).Investigation summary: complaint description: it was reported that the femur fractured and 4 control cables had to be used.Proposed solution :due to the booking been pushed through late the sales rep should have confirmed with the warehouse guys regarding the delivery time before committing 17:00 to the doctor.There is no information to suggest that the femoral fracture was in any way attributed to the product.The surgeon had deemed a size 17 as the correct size for the patient.From the information reviewed it was noted that it was unlikely that a manufacturing defect was present.The complaint shall be closed with a user error root cause.No corrective action is required.The occurrence shall be put monitored through our companies post market surveillance system for future trends.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
Complaint description: it was reported that the femur fractured and 4 control cables had to be used.

• Brand Name: RECLAIM DISTAL TAPERED 17X140
• Common Device Name: HIP FEMORAL STEM/SLEEVE
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork IN ; EI
• MDR Report Key: 6805117
• Report Number: 1818910-2017-23207
• Device Sequence Number: 1852578
• Product Code: KWA
• UDI-Device Identifier: 10603295077053
• UDI-Public: 10603295077053
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K102080
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: consumer,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/23/2017

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
• Operator of Device: Health Professional
• Device Catalogue Number: 197617140
• Device Lot Number: C53736
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/23/2017
• Supplement Date Received by Manufacturer: 02/26/2018
• Initial Report FDA Received Date: 08/18/2017
• Supplement Report FDA Received Date: 02/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention