MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIGMA HP UNI INS SZ2 8MM LM/RL; EARLY INTERVENTION : KNEE TIBIAL INSERT

Model Number	1024-53-208
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/02/2022
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 sigma partial knee insert doesn't fit with tibia tray.Doctor cannot inserted to tibia.There was a ten minute surgical delay.
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 (nc search) was performed for the finished device 102453208 , lot j8783m, and no non-conformances / manufacturing irregularities were identified.
Event or Problem Description
A.Please provide the hospital or account name.Answer: (b)(6) hospital b.It was indicated in the event description that ''early loosening / unstable.'' please clarify if these were the adverse consequences the patient experienced due to knee insert doesn't fit with tibia tray.Answer: normally when surgeon put insert to tibia it should be easy to put it to tibia but this case it¿s hard to put it and surgeon tried to put many times.He observed insert has unusual appearance.He think it¿s cause insert doesn't fit with tibia tray.B.Did the event happen during primary surgery or revision surgery? answer: primary c.If the event happened during a revision surgery, were there depuy products explanted? if yes, was the revision being reported? please provide the reference number.If none reported, please state the reason for revision surgery, product and lot number of all explanted depuy products.Additional information added: 1.Please confirm what the resolution was to the implant to implant fit issues.Answer: change size.
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.H10 additional narrative: added: b5 and d10 if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: SIGMA HP UNI INS SZ2 8MM LM/RL
• 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: 13548522
• Report Number: 1818910-2022-02967
• Device Sequence Number: 14733818
• Product Code: JWH
• UDI-Device Identifier: 10603295002499
• UDI-Public: 10603295002499
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 02/17/2022

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 Expiration Date: 07/31/2025
• Device Model Number: 1024-53-208
• Device Catalogue Number: 102453208
• Device Lot Number: J8783M
• 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: 02/02/2022
• Supplement Date Received by Manufacturer: 02/26/2022; 03/18/2022
• Initial Report FDA Received Date: 02/17/2022
• Supplement Report FDA Received Date: 03/03/2022; 03/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/12/2020
• 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: SIGMA HP UNI INS SZ2 8MM LM/RL; SIGMA HP UNI INS SZ2 8MM LM/RL; SIGMA HP UNI INS SZ2 8MM LM/RL; UNKNOWN KNEE TIBIAL TRAY
• Patient Sex: Unknown