MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US LPS EXTRACTOR ADAPTER MORELAND; HIP INSTRUMENTS : EXTRACTION INSTRUMENTS

Catalog Number	298772045
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/11/2017
Type of Reportable Event	Malfunction
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
It was reported that the surgeon was attempting to remove an lps stem from the patient's femur he had implanted six weeks earlier when the threaded part of the adapter broke off cleanly.Surgeon had to shift gears and cut off the stem with a midas rex so he could slip a trephine over it and ream the bone to eventually remove the stem from the femur.No surgical delay.All pieces were retrieved from the patient.
Additional Manufacturer Narrative
(b)(4).The device associated with this report was not received for examination.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, a follow-up medwatch will be filed as appropriate.

• Brand Name: LPS EXTRACTOR ADAPTER MORELAND
• Common Device Name: HIP INSTRUMENTS : EXTRACTION INSTRUMENTS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 7171489
• Report Number: 1818910-2018-50486
• Device Sequence Number: 13707187
• Product Code: HWB
• UDI-Device Identifier: 10603295159162
• UDI-Public: 10603295159162
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2017

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: 298772045
• Device Lot Number: AG2079907
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/11/2017
• Supplement Date Received by Manufacturer: 09/27/2018
• Initial Report FDA Received Date: 01/08/2018
• Supplement Report FDA Received Date: 09/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Weight: 105