MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ANTHEM PS HF INSERT SZ 3-4 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	71422668
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/28/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during tka surgery, an anthem ps hf insert sz 3-4 11 mm insert broke while instruments were inside patient.A delay of less than 30 minutes occurred due to this event, and the procedure was concluded using a smith and nephew backup insert.Neither patient injury nor other complications were reported.
Additional Manufacturer Narrative
Section b5 was updated with the new information received.Internal complaint reference number: case-2021-00057296-1 section h1 and h6 were corrected according to the new information received.
Event or Problem Description
It was reported that, during tka surgery, an anthem ps hf insert sz 3-4 11mm (case-2021-00057296-1) insert was noticed to be broken when the packaging was opened before use.A delay of less than 30 minutes occurred due to this event, and the procedure was concluded using a smith and nephew backup insert.Neither patient injury nor other complications were reported.
Additional Manufacturer Narrative
Section: h3, h6: the device, used in treatment, was not returned for evaluation.The images provided were reviewed a fracture was found, but the out of box failure could not be confirmed.A review of the complaint history did not reveal additional complaints for the listed batch.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we have no evidence to suspect that the product failed to meet any product specifications at the time of manufacture.With no other complaints for the batch, and no evidence that this type of damage can happen during the manufacturing process, probable causes could include but are not limited to surgical technique or an isolated event.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.Should the device or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: ANTHEM PS HF INSERT SZ 3-4 11MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 12011128
• Report Number: 1020279-2021-05191
• Device Sequence Number: 4328781
• Product Code: JWH
• UDI-Device Identifier: 00885556583937
• UDI-Public: 00885556583937
• Combination Product (Y/N): N
• Initial Reporter Country: TS
• PMA/510(K) Number: K032295
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/16/2021

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: 71422668
• Device Catalogue Number: 71422668
• Device Lot Number: 19HM21323
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 05/29/2021
• Supplement Date Received by Manufacturer: 06/26/2021; 11/15/2021
• Initial Report FDA Received Date: 06/16/2021
• Supplement Report FDA Received Date: 06/29/2021; 11/16/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/26/2019
• 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 Sex: Unknown