MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIGMA HP UNI INS SZ5 8MM RM/LL; EARLY INTERVENTION : KNEE TIBIAL INSERT

Model Number	1024-54-508
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/01/2021
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 on insertion of the poly insert, it was noted that it was not seating anteriorly.The poly was removed and the checks on cement over hang and debris in the tray took place.It was then re inserted but again did not fully seat.The steps were repeated again but at this time it was noted the poly had deformation anteriorly due to being impacted to try and seat it, but possible damge to the poly locking rails on the underside of the insert were observed.The poly was removed and swapped for an 8mm sz 5 rm, due to only 1 x 7mm being on the loan set.The surgeon noted the poly had a slight 1 mm spring anteriorly, however accepted this as he believed the poly to be securely in place.
Additional Manufacturer Narrative
Product complaint (b)(4).Investigation summary: no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot: a manufacturing record evaluation was performed for the finished device 102454508, lot j4609u, and no non-conformances / manufacturing irregularities were identified.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
Additional information received indicated that the affected side involved in this event was the right knee medial side rm.

• Brand Name: SIGMA HP UNI INS SZ5 8MM RM/LL
• Common Device Name: EARLY INTERVENTION : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 13017606
• Report Number: 1818910-2021-28259
• Device Sequence Number: 14749671
• Product Code: HRY
• UDI-Device Identifier: 10603295002949
• UDI-Public: 10603295002949
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K070267
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/16/2021

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 Model Number: 1024-54-508
• Device Catalogue Number: 102454508
• Device Lot Number: J4609U
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/02/2021
• Supplement Date Received by Manufacturer: 12/17/2021; 01/25/2022
• Initial Report FDA Received Date: 12/16/2021
• Supplement Report FDA Received Date: 01/12/2022; 01/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/08/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PALACOS CEMENT; SIGMA HP UNI FEMORAL SZ5 RM/LL; SIGMA HP UNI INS SZ5 7MM RM/LL; SIGMA HP UNI TIB TRAY SZ5 RMLL
• Patient Sex: Unknown