MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN PS HIGH FLEX XLPE SZ 7-8 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	71453232
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	05/02/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Event or Problem Description
It was reported that, after a tka performed on (b)(6) 2013, on (b)(6) 2022 the post broke off the legion posterior stabilized high flex highly cross linked polyethylene size 7-8 11mm.This was addressed via revision surgery on (b)(6) 2022 to replace the insert.Current health status of the patient is unknown.
Additional Manufacturer Narrative
H3, h6: the device was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, based on a review of the information provided, the root cause of the breakage of the post on the insert could not be determined.However, the patient¿s body habitus of 305 pounds, age, activity level, and bone quality could not be ruled out as a possible contributory factor.According to the report, the legion posterior stabilized high flex highly cross-linked polyethylene size 7-8 11mm was replaced and no other parts were affected.It should also be noted the implant was implanted 9 years prior to the revision.The patient impact was instability, locking, pain, fractured post, the subsequent revision, and expected transient post-op convalescence period.According to the report, the patient¿s current health status is healthy.Therefore, no further clinical/medical assessment is warranted at this time.A review of the production order did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history revealed similar events for the listed device over the previous 12 months, but no similar events for the batch based on the historical data, 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 that the implant can break or become damaged as a result of strenuous activity or trauma, and has a finite expected service life and may need to be replaced in the future.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.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Factors that could contribute to the reported event include traumatic injury, size selected, surgical technique or postoperative care.The contribution of the device to the reported event could not be corroborated.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: LGN PS HIGH FLEX XLPE SZ 7-8 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: 15307960
• Report Number: 1020279-2022-03861
• Device Sequence Number: 2797916
• Product Code: JWH
• UDI-Device Identifier: 00885556035153
• UDI-Public: 00885556035153
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K071071
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/05/2022

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: 09/13/2020
• Device Model Number: 71453232
• Device Catalogue Number: 71453232
• Device Lot Number: 10JM09692
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/10/2022
• Supplement Date Received by Manufacturer: 10/04/2022
• Initial Report FDA Received Date: 08/28/2022
• Supplement Report FDA Received Date: 10/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/16/2010
• 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: Male
• Patient Weight: 138 KG