MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 UNIVERSAL STEM 115X22MM FLUTED; FEMORAL STEM

Catalog Number	867434
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Code Available (3191)
Date of Event	11/20/2017
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
Der states that they reamed the femur to 22x115 put our trial in and the stem engaged and fit snug.When putting in the actual implant the stem just fell right into the femoral canal, they checked the implant with a caliper and it was measuring at 20mm.They ended up opening a second 22mm and it resulted in the same results.They finished by putting in a 24x115 and it fit snug.
Additional Manufacturer Narrative
Investigation summary: the device associated with the reported event was not returned.Review of the device history records did not reveal any manufacturing deviations or anomalies.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.Device history lot: null.Device history batch: null.Device history review: null.If information is obtained that was not available for the initial medwatch , a follow-up medwatch, will be filed as appropriate.
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
There was a surgical delay of 1 hour.

• Brand Name: UNIVERSAL STEM 115X22MM FLUTED
• Common Device Name: FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7116613
• Report Number: 1818910-2017-51623
• Device Sequence Number: 19199984
• Product Code: JWH
• UDI-Device Identifier: 10603295217947
• UDI-Public: 10603295217947
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K063633
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/20/2017

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 867434
• Device Lot Number: 317383
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/20/2017
• Supplement Date Received by Manufacturer: 09/24/2018; 11/09/2018; 11/29/2017
• Initial Report FDA Received Date: 12/14/2017
• Supplement Report FDA Received Date: 10/05/2018; 11/09/2018; 11/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 46 YR