MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIG FEM ADAP +2/-2 OFFSET BOLT; SIGMA REVISION IMPLANT : KNEE FEMORAL ACCESSORY

Catalog Number 960784

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 01/17/2024

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).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, or its employees that the report constitutes an admission that the product, depuy synthes, 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 Description

Patient was revised due to nickel allergy.Doi: unknown.Dor: (b)(6), 2024.Affected side: right knee.

Manufacturer Narrative

Product complaint (b)(4).Investigation summary: no device associated with this report was received for examination.In order to determine, if a lot related issue was possible.A worldwide complaint database search was performed.A worldwide complaint database search found, no additional related reports against the provided product code/lot code combination.Based on the inability to find any additional related reports 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.As part of our company quality system process, all devices are manufactured, inspected and distributed to approved specifications.Additional complaint information, monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.If additional information is made available, the investigation will be updated as applicable.Device history lot: the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

• Brand Name: SIG FEM ADAP +2/-2 OFFSET BOLT
• Type of Device: SIGMA REVISION IMPLANT : KNEE FEMORAL ACCESSORY
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 18570768
• MDR Text Key: 333603024
• Report Number: 1818910-2024-01676
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10603295233947
• UDI-Public: 10603295233947
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K060515
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/24/2024

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 960784
• Device Lot Number: HW8227
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/17/2024
• Initial Date FDA Received: 01/24/2024
• Supplement Dates Manufacturer Received: 02/09/2024
• Supplement Dates FDA Received: 02/09/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/08/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: MBT TRAY SLEEVE POR M/L 45MM; PFC SIGMA FEM POST AUG SZ4 4MM; PFC SIGMA FEM POST AUG SZ4 4MM; PFC*SIGMA DIS AUG 4MM,SZ4,RGHT; PFC*SIGMA DIS AUG 4MM,SZ4,RGHT; PFC*SIGMA TC3 FEM RT SZ4; PFC*SIGMA/OV/DOME PAT 3PEG,41; SIGMA FEM ADAPTER 5 DEGREE; UNIVERSAL STEM 75X20MM FLUTED
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR
• Patient Sex: Female