MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PFC*SIGMA DI AUG16MMCO,SZ4RGHT; SIGMA REVISION IMPLANT : KNEE FEMORAL ACCESSORY

Model Number	96-0892
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2021
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
Procedure: knee recovery.The 2 packagings of the implant have holes (maybe made by the device itself).However, the box of the implant was intact (hermetic and did not have holes).Date of the event: (b)(6) 2021.The incident occurred during the surgery.Delay : 5 min, time to take another implant and to make the final assembly for the surgery.
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
The incident occurred during the surgery with a 5 minutes delay time to take another implant and to make the final assembly for the surgery.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device or associated packaging components were received for examination.Depuy synthes considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Device history lot: a dhr review was conducted by the manufacturing site.The dhr review revealed, one unrelated nonconformance (nr-0036132) associated with the provided product code and lot combination.
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: d9.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Corrected: h3.
Additional Manufacturer Narrative
Product complaint #(b)(4).Investigation summary: the overall all complaint was not confirmed due to none of the packing components were returned with the device.There was no indication of a design or manufacturing issue with the returned device.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post market surveillance.Device history lot: a dhr review was conducted by the manufacturing site.The dhr review revealed, no related nonconformance associated with the provided product code and lot combination (p/n 960892, lot c12235).

• Common Device Name: SIGMA REVISION IMPLANT : KNEE FEMORAL ACCESSORY
• 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: 11561802
• Report Number: 1818910-2021-05934
• Device Sequence Number: 4183132
• Product Code: JWH
• UDI-Device Identifier: 10603295234456
• UDI-Public: 10603295234456
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,Followup,Followup
• Report Date (Section B): 03/04/2021

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: 96-0892
• Device Catalogue Number: 960892
• Device Lot Number: C12235
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 03/04/2021
• Supplement Date Received by Manufacturer: 03/19/2021; 06/07/2021; 09/23/2021; 10/24/2022
• Initial Report FDA Received Date: 03/24/2021
• Supplement Report FDA Received Date: 03/29/2021; 06/07/2021; 09/27/2021; 10/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/14/2016
• 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
• Patient Sex: Unknown