MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JOURNEY PF IMPLANT MED LT; PROSTHESIS, KNEE, PATELLO/FEMORAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	71461014
Medical Device Problem Codes	Degraded (1153); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Ambulation or Postural Difficulties (2544); Crepitus (4893)
Date of Event	12/26/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 submitting this report in accordance with applicable regulations.If additional investigative findings or 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) 2019, the patient experienced patella clunk.This adverse event was addressed by a revision surgery on (b)(6) 2024, in which they revised the implants to a total knee, and revised one (1) journey pf implant med lt by explanting it and noticed it to have more wear than expected.The current health status of the patient is unknown.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).Additional information: d5, d7a, d8, e1 (name prefix/title), h8 corrected data: b1, b5, h6 (medical device problem code, health effect - clinical code).
Event or Problem Description
It was reported that, after a pfj surgery that had been performed on (b)(6) 2019, the patient experienced patella clunk.This adverse event was addressed by a revision surgery on (b)(6) 2024, in which they revised the implants to a tka; also the patella was noticed to have more wear than expected so it was revised too.The current health status of the patient is unknown.
Additional Manufacturer Narrative
H10: (b)(4) was found to be a duplicate of (b)(4); since both cases cover the same revision surgery performed due to the patient experiencing a patellar clunk.Therefore, (b)(4) (where the journey pf implant med lt was reported) will be closed and (b)(4) (where the gii/legion resurf pat w/jrny peg 29mm was reported) will remain open.The investigation and findings for both implants will be documented under (b)(4).From now on, this report will be covered under report number: (b)(4).

• Brand Name: JOURNEY PF IMPLANT MED LT
• Common Device Name: PROSTHESIS, KNEE, PATELLO/FEMORAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• 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: 21200376
• Report Number: 1020279-2025-00149
• Device Sequence Number: 8285253
• Product Code: KRR
• UDI-Device Identifier: 03596010544216
• UDI-Public: 3596010544216
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K051086
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/06/2025

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 Catalogue Number: 71461014
• Device Lot Number: 19BM19715
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/27/2024
• Supplement Date Received by Manufacturer: 02/13/2025; Not provided
• Initial Report FDA Received Date: 01/21/2025
• Supplement Report FDA Received Date: 02/19/2025; 03/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/25/2019
• 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 Age: 64 YR
• Patient Sex: Female