MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII OVAL RESURFACING PAT 29MM; PRSTHIS, KNEE,SEMI-CNSTRIND, CMNTD, POLYMER/MTL/PLYMR

Model Number	71421029
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	Injury (2348)
Date of Event	12/12/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after closing the incision it was noticed that during flexion the patella made a clinking sound.It could happen because the 29 mm patella used was too small.The patella was removed and placed a bigger one from a competitor.
Additional Manufacturer Narrative
Results of investigation: it was reported that after closing the incision it was noticed that during flexion the patella made a clinking sound.It could happen because the 29 mm patella used was too small.The patella was removed and placed a bigger one from a competitor.The affected genesis ii oval resurfacing patellar component, used in treatment, was not returned for evaluation.Therefore a product analysis could not be performed.Our investigation including a review of the manufacturing records for the listed batch did not reveal any deviation from the standard manufacturing processes.A review of the complaint history for the listed part revealed no prior complaints for the listed failure mode with the same batch number.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A relationship, if any, between the device and the reported incident could not be corroborated.No medical documents were received for investigation.Therefore no medical assessment can be performed at this time.Review of the instructions for use and risk management files identified the reported failure as potential adverse events.Possible causes could include but are not limited to size of device or alignment.Based on this investigation, the need for corrective action is not indicated.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: GII OVAL RESURFACING PAT 29MM
• Common Device Name: PRSTHIS, KNEE,SEMI-CNSTRIND, CMNTD, POLYMER/MTL/PLYMR
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9553556
• Report Number: 1020279-2020-00114
• Device Sequence Number: 16634289
• Product Code: JWH
• UDI-Device Identifier: 03596010485052
• UDI-Public: 03596010485052
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K951987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/28/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: 71421029
• Device Catalogue Number: 71421029
• Device Lot Number: 19HM02936
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2021
• Initial Date Received by Manufacturer: 12/12/2019
• Supplement Date Received by Manufacturer: 12/12/2019; 12/12/2019
• Initial Report FDA Received Date: 01/06/2020
• Supplement Report FDA Received Date: 05/06/2020; 04/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention