MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIGMA HP UNI INS SZ5 7MM LM/RL; EARLY INTERVENTION : KNEE TIBIAL INSERT

Catalog Number	102453507
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); Not Applicable (3189)
Date of Event	03/29/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Investigation summary: no device associated with this report was 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.Device history lot: (b)(4), lot number hj7564; device history batch: null.Device history review: review of device history records finds no related manufacturing deviations or anomalies on the reported lot number ((hj7564).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 the surgeon had struggles with implanting the original poly.He removed some additional soft tissues that may be causing the issue and continued to try to insert the poly.He asked for a second poly when the original had gotten beat up a little in the implant process.The second poly seemed to snap in with no problems at all.The surgeon was pleased with the final product and began the closing process.Doe: (b)(6) 2018; left knee.

• Brand Name: SIGMA HP UNI INS SZ5 7MM LM/RL
• Common Device Name: EARLY INTERVENTION : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 7457549
• Report Number: 1818910-2018-58177
• Device Sequence Number: 13717052
• Product Code: HRY
• UDI-Device Identifier: 10603295002635
• UDI-Public: 10603295002635
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K070267
• 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
• Report Date (Section B): 03/29/2018

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: 102453507
• Device Lot Number: HJ7564
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/29/2018
• Initial Report FDA Received Date: 04/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1