MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII PS HI FLEX ISRT SZ 5-6 11; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	71421516
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Joint Laxity (4526)
Date of Event	09/03/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).This complaint was opened by smith+nephew to document a patient complication related to a product problem with a smith+nephew device.The reported issue(s) relate to known inherent device and/or procedural risks that are appropriately documented in our risk files.Smith+nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.Smith+nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture.Based on our review of all currently available information, we are unable to identify a definitive root cause.However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are conservatively submitting this report in accordance with applicable regulations.If additional information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required.
Event or Problem Description
It was reported that, after a tka surgery that had been performed on (b)(6) 2007, the patient experienced knee instability and uncomfortableness as the post of one (1) gii ps hi flex isrt sz 7-8 11 had broken.This adverse event was solved by a revision surgery on (b)(6) 2024, in which a new ps insert was implanted.The current health status of the patient is unknown.
Additional Manufacturer Narrative
B5, d1, d4: updated.
Event or Problem Description
It was reported that, after a tka surgery that had been performed on (b)(6) 2007, the patient experienced knee instability and uncomfortableness as the post of one (1) gii ps hi flex isrt sz 5-6 11 had broken.This adverse event was solved by a revision surgery on (b)(6) 2024, in which a new ps insert was implanted.The current health status of the patient is unknown.
Additional Manufacturer Narrative
Sections a2, a3, a4, d9 and h6 were updated.Section h10: the associated device was returned and evaluated.The visual inspection revealed that the post fractured off.The piece was returned.The visual also reveals discoloration, scratches and gouges.The explant shows signs of significant wear and use.This inspection was conducted by naked eye.The clinical/medical investigation concluded that based on the information provided the clinical root cause of the reported knee instability and uncomfortableness was the result of the implant breakage.The cause for the breakage could not be determined based on the limited information provided.Per the instructions for use for knee system ¿the patient should be warned that the device does not replace normal healthy bone, and that the implant can break or become damaged as a result of strenuous activity or trauma, and it has a finite expected service life and may require replacement in the future.¿ it cannot be concluded that the reported event is related to a malperformance of the implant or implant failure versus the time of over 17 years of being implanted.The patient impact is determined to be the revision and a brief post-operative recovery phase would be anticipated.A review of the production order did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.The knee insert post deformation and/or fracture may have been due to repeated posterior contact of the femoral cam on the post combined with excessive posterior to anterior shear force during activity.However, this could not be isolated as the root cause for this particular failure mode.Based on the conclusions of the product history review and the device evaluation, further product evaluation is not required because there is no evidence that a manufacturing deficiency occurred.A review of complaint history revealed a similar event for the listed device over the previous 12 months, but no similar events for the batch based on the historical data, however, no commonalities that would suggest a device deficiency was found nor an adverse trend.This failure mode will be monitored for future complaints for any necessary corrective actions.A review of the instructions for use documents for knee systems revealed in warnings and precautions that the implant can break or become damaged as a result of strenuous activity or trauma.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.A historical review concluded that there are no prior actions related to this product and event.According to the material specification, the quality and manufacture of ultra-high-molecular-weight polyethylene (uhmwpe) shall be controlled.At this time, we have no evidence to conclude that the product failed to meet any specifications at the time of manufacture.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 for future complaints and investigate as necessary.Internal complaint reference: (b)(4).

• Brand Name: GII PS HI FLEX ISRT SZ 5-6 11
• 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: 20286126
• Report Number: 1020279-2024-01916
• Device Sequence Number: 7235624
• Product Code: JWH
• UDI-Device Identifier: 03596010492333
• UDI-Public: 3596010492333
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K032295
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/08/2024

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/01/2016
• Device Catalogue Number: 71421516
• Device Lot Number: 06GT99757
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/03/2024
• Supplement Date Received by Manufacturer: 09/27/2024; 11/05/2024
• Initial Report FDA Received Date: 09/23/2024
• Supplement Report FDA Received Date: 09/30/2024; 11/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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; Hospitalization
• Patient Age: 82 YR
• Patient Sex: Male
• Patient Weight: 102 KG