MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIGMA HP UNI INS SZ2 7MM LM/RL; EARLY INTERVENTION : KNEE TIBIAL INSERT

Catalog Number	102453207
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/18/2018
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
Insert was not locking on tibial implant.
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 there was a 20 minutes surgical delay.
Additional Manufacturer Narrative
Product complaint investigation summary the device was returned and confirmed damage to the locking mechanism.The root cause is undetermined.Depuy synthes considers the investigation closed at this time.Device history lot hd7708 device history review no anomalies or deviations were found during the review for routed phases.

• Brand Name: SIGMA HP UNI INS SZ2 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: 7923888
• Report Number: 1818910-2018-70972
• Device Sequence Number: 13821313
• Product Code: HRY
• UDI-Device Identifier: 10603295002482
• UDI-Public: 10603295002482
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K070267
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/18/2018

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: 102453207
• Device Lot Number: HD7708
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2018
• Initial Date Received by Manufacturer: 09/18/2018
• Supplement Date Received by Manufacturer: 11/01/2018; 11/05/2018
• Initial Report FDA Received Date: 10/01/2018
• Supplement Report FDA Received Date: 11/02/2018; 11/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1