MAUDE Adverse Event Report: SMITH & NEPHEW, INC. PRO METAPH TIB STEM 18MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	71501010
Medical Device Problem Codes	Fracture (1260); Failure to Osseointegrate (1863); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Arthralgia (2355); Inadequate Osseointegration (2646); Radiolucent Lines (4848)
Date of Event	08/16/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: case-(b)(4).
Event or Problem Description
It was reported that, after left tka surgery had been performed on (b)(6) 2022, the patient experienced pain.Furthermore, x-rays showed lucency under the lgn por ha tib base w/o holes sz 7 lt.This adverse event was treated with revision surgery performed on (b)(6) 2023, in which a lgn por ha tib base w/o holes sz 7 lt was exchanged.Patient as far as acknowledged is fit and healthy.
Event or Problem Description
It was reported that, after left tka surgery had been performed on (b)(6) 2022, the patient experienced pain.Furthermore, x-rays on (b)(6) 2023 showed lucency under the tibial component particularly in the pro metaph tib stem 18mm, this findings would suggest loosening of the protheses.This adverse event was treated with revision surgery performed on (b)(6) 2023, in which a lgn por ha tib base w/o holes sz 7 lt, pro metaph tib stem 18mm and a lgn cr high flex xlpe sz 7-8 9mm were exchanged.Patient as far as acknowledged is fit and healthy.
Additional Manufacturer Narrative
H3, h6: the associated devices were returned and evaluated.A visual inspection of the returned stem reveals pieces of the stem fractured off.These pieces were not returned.Also the visual of the insert reveals signs of wear.The clinical/medical investigation concluded that, based on the reported x-ray findings, prosthetic loosening led to the revision and contributed to the patient¿s pain.The patient impact included the reported pain and bilateral tibial lucency/component loosening with subsequent revision bilaterally.The patient was ¿as far as acknowledged fit and healthy¿, but a post-surgical restorative phase would be anticipated.A review of the production orders did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.For the stem and the insert, a review of complaint history revealed a similar event for the listed devices over 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.For the tibial baseplate, a review of complaint history for the part number over 12 months and for the batch number based on historical data of the device did not reveal similar events for the listed device.A review of the instructions for use documents for knee systems revealed that looseness of components has been identified in possible adverse effects section as a result from trauma, improper implant selection, improper implant positioning, improper fixation, and/or migration of the components.Muscle and fibrous tissue laxity can also contribute to these conditions.Also, warnings and precautions revealed that the implant can break or become damaged as a result of strenuous activity or trauma.A review of the risk management files 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 these products and event.For the stem, according with the inspection procedure, the final inspection includes the verification of part configuration per print.Also, per material specification, the quality and manufacture of standard grade titanium, aluminum and vanadium alloy shall be controlled.At this time, we have no reason to suspect that the products failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include abnormal motion over time, bone degeneration, abnormal loading of limb, excessive forces, patient condition and/or traumatic injury.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.We consider this investigation closed.

• Brand Name: PRO METAPH TIB STEM 18MM
• 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: 18238074
• Report Number: 1020279-2023-02364
• Device Sequence Number: 20622978
• Product Code: JWH
• UDI-Device Identifier: 03596010218391
• UDI-Public: 03596010218391
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K933958
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/12/2024

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 71501010
• Device Lot Number: 20ETX0036N
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/09/2023
• Supplement Date Received by Manufacturer: 11/30/2023; 01/11/2024
• Initial Report FDA Received Date: 11/30/2023
• Supplement Report FDA Received Date: 12/06/2023; 01/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/22/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 71453131/22EM02783/LGN CR HIGH FLEX XLPE SZ 7-8 9M.; 71453131/22EM02783/LGN CR HIGH FLEX XLPE SZ 7-8 9M.; 71501010/20ETX0036N/PRO METAPH TIB STEM 18MM.; 71934166/20HM06393/LGN POR HA TIB BASE W/O HOLES S.
• Patient Sex: Unknown