MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIGMA STAB GVF INS 2 8MM; SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT

Model Number	1581-21-008
Medical Device Problem Codes	Difficult to Insert (1316); Device Damaged Prior to Use (2284)
Health Effect - Clinical Codes	Unspecified Tissue Injury (4559); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/19/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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
Unable to assemble.The patient underwent knee arthroplasty on (b)(6) 2022.During the surgery, it was found that the backside of the insert has the protruding problem, which resulted in that the insert could not be implanted with the tibial plateau.Another device was used to complete the surgery.This resulted in a 2 mm increase in patient bone cutoff.The patient was in stable condition now.Right knee.
Event or Problem Description
Additional information received indicated that the surgeon did not make multiple cuts but directly used the lager size insert (10 mm one).
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this complaint was received for examination.The photo investigation found 1 of the bottom assembly tabs slightly bent, which is reasonable to confirm a difficulty or inability on assembling the device, however this issue cannot be traced to a manufacturing issue.The evidence provided supports the usage or intent of usage of the device intraoperatively, therefore the reported allegation for damage upon receipt cannot be confirmed since there are no evidence of the event before the implantation intent.No device associated with this report was received for examination.Depuy synthese 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 : a search of the depuy nonconformance (nc) quality system found no nc¿s associated with this product/lot combination.Based on the inability to find any nc¿s against the provided product code/lot code combination, it is reasonable to conclude that there are no anomalies with regard to manufacturing or inspection contained in the device history records that would contribute to the reported event.
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.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary no device associated with this complaint was received for examination.The photo investigation found 1 of the bottom assembly tabs slightly bent, which is reasonable to confirm a difficulty or inability on assembling the device, however this issue cannot be traced to a manufacturing issue.The evidence provided supports the usage or intent of usage of the device intraoperatively, therefore the reported allegation for damage upon receipt cannot be confirmed since there are no evidence of the event before the implantation intent.No device associated with this report was received for examination.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 a search of the depuy nonconformance (nc) quality system found no nc¿s associated with this product/lot combination.Based on the inability to find any nc¿s against the provided product code/lot code combination, it is reasonable to conclude that there are no anomalies with regard to manufacturing or inspection contained in the device history records that would contribute to the reported event.,a search of the depuy nonconformance (nc) quality system found no nc¿s associated with this product/lot combination.Based on the inability to find any nc¿s against the provided product code/lot code combination, it is reasonable to conclude that there are no anomalies with regard to manufacturing or inspection contained in the device history records that would contribute to the reported event.

• Brand Name: SIGMA STAB GVF INS 2 8MM
• Common Device Name: SIGMA KNEE PRIMARY : 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: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 15751926
• Report Number: 1818910-2022-22353
• Device Sequence Number: 6317055
• Product Code: JWH
• UDI-Device Identifier: 10603295063926
• UDI-Public: 10603295063926
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K033272
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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,Followup
• Report Date (Section B): 11/08/2022

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 Model Number: 1581-21-008
• Device Catalogue Number: 158121008
• Device Lot Number: JD8546
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/22/2022
• Supplement Date Received by Manufacturer: 11/09/2022; 11/16/2022; 12/06/2022
• Initial Report FDA Received Date: 11/08/2022
• Supplement Report FDA Received Date: 11/10/2022; 11/18/2022; 12/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/21/2021
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR
• Patient Sex: Unknown