MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY 7.5 RND RSRF PAT 32MM STD; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	71420546
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Joint Laxity (4526); Implant Pain (4561)
Date of Event	12/06/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).
Event or Problem Description
It was reported that the plaintiff underwent a fifth revision surgery of the left knee due to instability and extensor mechanism insufficiency on (b)(6) 2016.The procedure comprised the revision surgery, a total patellectomy, and reconstruction of chronic extensor mechanism insufficiency with calcaneal bone block achilles tendon allograft with repair of quadriceps and patellar tendons.During the revision, the insert was explanted and replaced.After the procedure, the plaintiff kept having the impression that her knee was getting worse, however, no more interventions were performed.The fourth revision surgery was performed on (b)(6) 2015, the third revision surgery was performed on (b)(6) 2015, the second revision surgery was performed on (b)(6) 2015, the first revision surgery was performed on (b)(6) 2014 and the primary left knee tkr surgery was performed on (b)(6) 2014.
Additional Manufacturer Narrative
Section h3, h6: the reported event was analyzed.Although the involvement of all the devices was reported, the relationship with the investigated failure was directly associated to the round resurface patella.Therefore, no investigation is deemed for the other devices.The device was not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that, although instability of the knee was reported, the surgeon was unable to assess any instability intraoperatively.Based on the information provided, the patient¿s previous multiple revision and surgeries and non-compliance with weightbearing cannot be ruled out as contributing factors to the patient¿s reported clinical symptoms as well as intraoperative findings.Post revision, the patient was noted to have genu valgus at the mid-tibia shaft, but well-fixed components, and eventually had an unknown external fixator placed to correct as well as hydrotherapy.One year post revision, the patient reported an improvement in the strength of her leg with therapy.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 looseness of components 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, this has been identified as possible adverse effects.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 specifications at the time of manufacture.Factors that could contribute to the reported event include size selected, joint laxity or patient condition.Based on this investigation, the need for corrective action is not indicated.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.H6:medical device problem code.

• Brand Name: JRNY 7.5 RND RSRF PAT 32MM STD
• 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: 17197367
• Report Number: 1020279-2023-01361
• Device Sequence Number: 6591821
• Product Code: JWH
• UDI-Device Identifier: 00885556058398
• UDI-Public: 885556058398
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K042515
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/11/2023

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: 03/08/2025
• Device Model Number: 71420546
• Device Catalogue Number: 71932912
• Device Lot Number: 15CM06983
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/31/2023
• Supplement Date Received by Manufacturer: 07/07/2023; 07/07/2023
• Initial Report FDA Received Date: 06/26/2023
• Supplement Report FDA Received Date: 07/07/2023; 07/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/15/2010
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 71420546 / LOT# 10KM10807.; 71421167 / LOT# 14MM03157.; 71421673 / LOT# 96CM08802.; 71421766 / LOT# 06BM17171.; 71424005 / LOT# 14KM03149.; 71424048 / LOT# 14JSM034E.; 71424069 / LOT# 14ESM0182C.; JRNY 7.5 RND RSRF PAT 32MM STD, LOT#:15CM06983.; LGN OX CONSTRAINED FEM 7 LT, LOT#:14MM03157.; LGN PRSFT STEM 16MMX220MM STRT, LOT#:14ESM0182C.; LGN REV TIBIA BASE SZ 5 LT, LOT#:14KM03149.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 58 YR
• Patient Sex: Female
• Patient Weight: 91 KG