MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIGMA CRVD GVF INS 3 8MM; SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT

Model Number	1581-13-008
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/19/2021
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 the implant did not fit correctly.
Event or Problem Description
1.Based on the email attached the implant was not fitting.Clarify what do you mean by fitting.Was it implant to bone fit or implant to implant fit? surgeon reported to the staff that the tibial insert was not engaging with the tibial tray and therefore had to open a new tibial insert.(implant to implant fit) 2.Was surgery time extended? if yes, what was the duration of the delay? yes, 15 minutes.3.Was the reported implant available for return? yes.4.Please clarify what you mean by "description of damage: packaging - written on"? this was found in the attached excel file - (b)(4).I don¿t know what this means.5.Implant insertion op notes:- please provide all notes relevant to the reported event for example: - - reason for implant insertion, device labels, surgery report, physiotherapy report, early falls and/or dislocations.Not applicable.
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 d9.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Corrected: h3 and h6 (patient).
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: the received device was forwarded to commercialized product development at depuy warsaw for evaluation.The reported condition was confirmed.The investigation found no evidence of product malfunction or product error and the need for corrective action was not established.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: 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 CRVD GVF INS 3 8MM
• Common Device Name: SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 12413183
• Report Number: 1818910-2021-19158
• Device Sequence Number: 4698675
• Product Code: JWH
• UDI-Device Identifier: 10603295063322
• UDI-Public: 10603295063322
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K033272
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/13/2021

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 Expiration Date: 02/28/2026
• Device Model Number: 1581-13-008
• Device Catalogue Number: 158113008
• Device Lot Number: D21030719
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2021
• Initial Date Received by Manufacturer: 08/13/2021
• Supplement Date Received by Manufacturer: 09/07/2021; 11/01/2021
• Initial Report FDA Received Date: 09/02/2021
• Supplement Report FDA Received Date: 09/16/2021; 11/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1