MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII PS HI FLEX ISRT SZ 5-6 9; PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMICONSTRAINED,CEMENTED,POLYMERMETALPOLYMER

Model Number	71421515
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Event or Problem Description
It was reported that, during tka surgery, a gii ps hi flex isrt sz 5-6 9 was unable to be implanted normally, it was falling out as soon it was reset.The physician tried more than 10 times, without success.Surgery was resumed, after a delay greater than 30 minutes, with a back-up device (a 5-6 11 mm insert).Patient was not injured as consequence of this problem.
Additional Manufacturer Narrative
H3, h6: the associated device was returned and evaluated.The contribution of the device to the reported event could not be corroborated.A visual inspection of the returned device does not confirm the stated failure mode.The returned insert has damage among the base, more than likely from attempted insertion.A dimensional inspection was attempted, but the device was too damaged from the attempted insertion to obtain accurate measurements.A review of complaint history revealed similar events for the listed device, but no similar events for the batch, this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.Assessment of historical escalated cases concluded that there are no prior actions related to this device and failure mode.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.Some potential probable causes for this event could include a fit/ sizing issue or poor insertion technique.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: GII PS HI FLEX ISRT SZ 5-6 9
• Common Device Name: PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMICONSTRAINED,CEMENTED,POLYMERMETALPOLYMER
• 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: 12844282
• Report Number: 1020279-2021-08276
• Device Sequence Number: 17163989
• Product Code: JWH
• UDI-Device Identifier: 03596010492371
• UDI-Public: 03596010492371
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K032295
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/28/2021

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: 71421515
• Device Catalogue Number: 71421515
• Device Lot Number: 19GM02466
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/02/2021
• Supplement Date Received by Manufacturer: 12/27/2021
• Initial Report FDA Received Date: 11/19/2021
• Supplement Report FDA Received Date: 12/28/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/03/2019
• 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
• Patient Age: 80 YR
• Patient Sex: Male