MAUDE Adverse Event Report: SMITH & NEPHEW, INC. PRO NON-POR TB BASE LT S2; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	71524220
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Osteolysis (2377)
Date of Event	12/06/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after a primary left profix tkr surgery performed on (b)(6) 2003, the patient experienced left knee pain from suspected implant loosening and query infection.Patient required a 1 stage knee revision surgery, in which the surgeon removed the following implants: profix non-por fem lt sz4, pro metaph tib stem 14mm, pro conf tb isrt lt s2 10 and pro non-por tb base lt s2; and sent them for sonification.The surgeon suspected infection of the tibial component, of the explanted devices the tibial component and tibial stem were suspected to have a problem.The single stage revision was completed with competitor system: stryker.Patient current health status is unknown.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Additional Manufacturer Narrative
H6: health effect - clinical code and health effect - impact code, section h3, h6: the devices were not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that, although it was reported that the surgeon suspected loosening and infection of the tibial components, the revision operative reports nor laboratory reports were provided for review.Since late onset infection post-prosthetic implantation (such as the reported suspected occurrence at approximately 19 years) is rare, the occurrence usually is a result from hematogenous spread (secondary bacteremia due to infection from another site).Therefore, based on the limited information provided, the clinical root cause of the reported events cannot be confirmed.The patient impact beyond the revision cannot be determined.No further clinical assessment is warranted at this time.A review of the production orders did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history for the part numbers over the past 12 months and for the batch numbers based on historical data of the device did not reveal similar events for the listed devices.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 infection has been identified as a possible adverse effect.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.Based on the clinical/medical evaluation conclusions, sterilization review was not performed.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, injury, patient condition and/or medical history.Based on this investigation, the need for corrective action is not indicated.Should the devices 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: PRO NON-POR TB BASE LT S2
• 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: 16062630
• Report Number: 1020279-2022-05114
• Device Sequence Number: 13961484
• Product Code: JWH
• UDI-Device Identifier: 03596010228925
• UDI-Public: 03596010228925
• 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: 2003
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/12/2023

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 Expiration Date: 05/28/2012
• Device Model Number: 71524220
• Device Catalogue Number: 71524220
• Device Lot Number: 02EM10292
• 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: 12/06/2022
• Supplement Date Received by Manufacturer: 06/08/2023
• Initial Report FDA Received Date: 12/28/2022
• Supplement Report FDA Received Date: 06/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/31/2002
• 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: PRO CONF TB ISRT LT S2 10, LOT#: 02FM09964.; PRO METAPH TIB STEM 14MM, LOT#:03AM10241.; PROFIX NON-POR FEM LT SZ4, LOT#:02CM05644.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 75 YR
• Patient Sex: Female