MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PFC SIGMA FEM POST AUG SZ2 4MM; SIGMA REVISION IMPLANT : KNEE FEMORAL ACCESSORY

Model Number	96-0826
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	01/31/2022
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 on (b)(6) 2022, a cast product cleanroom (cpcr) 2nd shift finish operator was performing the wi-0897 ¿repackaging / resterilization of sterile product in raynham¿ for a pfc sigma augment repackaging order.During this process, the operator identified multiple parts displayed a visual cosmetic defect on the top surface.The operator notified the finish lead, who contacted process and quality engineering for further evaluation.The image attached shows a augment returned from expiry with foam particles transferred from the packaging components.On (b)(6) 2021 12 parts were discovered with defects (captured on (b)(4)).On (b)(6) 2022, an additional 12 parts were discovered with defects (captured on (b)(4)).Later on (b)(6) 2022, an additional 29 parts were discovered with defects (captured on (b)(4)).
Additional Manufacturer Narrative
Product complaint (b)(4).Investigation summary: the device associated with this product investigation was not returned for evaluation.One photo was provided for review.However, the product code does not match this device.Therefore, the reported event could not be confirmed.Additional complaint information, monitoring for potential safety signals is conducted through complaint trending as part of post market surveillance.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: 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).Where the product and lot code was provided, a manufacturing records evaluation (mre) was not performed.

• Brand Name: PFC SIGMA FEM POST AUG SZ2 4MM
• 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 RAYNHAM, A DIV. OF DEPUY ORTHO 1219655; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 13593831
• Report Number: 1818910-2022-03526
• Device Sequence Number: 5819724
• Product Code: JWH
• UDI-Device Identifier: 10603295234104
• UDI-Public: 10603295234104
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2022

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 Model Number: 96-0826
• Device Catalogue Number: 960826
• Device Lot Number: 166043
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/31/2022
• Supplement Date Received by Manufacturer: 07/14/2022
• Initial Report FDA Received Date: 02/24/2022
• Supplement Report FDA Received Date: 07/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/02/2011
• 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
• Patient Sex: Unknown