MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ORTHOMATCH MOD PS FEM IMPLANT IMPACTOR; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	71442193
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H11: internal complaint reference: (b)(4).H3, h6: this complaint was opened by smith+nephew to document a product problem associated with a smith+nephew device.The reported problem relates 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 conservatively submitting this report in accordance with applicable regulations.If additional 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 during tka surgery one (1) orthomatch mod ps fem implant impactor broke after attempted to impact the definitive femoral component.The procedure was completed without delay using a s+n back-up device.No injury was reported as a consequence of this issue.
Additional Manufacturer Narrative
H3, h6: the device was not returned for evaluation.However, the photograph were reviewed, and revealed that the device is fractured along the body.A review of the production order did not reveal any manufacturing abnormalities that could have caused or contributed to the reported incident.A review of complaint history based on historical data revealed similar events for the listed batch.This failure mode will be monitored for future complaints and any necessary corrective actions.A review of the risk management file confirmed that this failure mode was previously identified.The anticipated risk level remains adequate.A historical review concluded that there are no prior actions related to this product or event.At this time, there is no evidence to suggest that the product failed to meet specifications at the time of manufacture.This device is a reusable instrument that may be exposed to multiple surgeries.Damage from prolonged use, misuse, or rough handling are likely contributing factors to the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage, and replaced as necessary.Based on this investigation, corrective action is not indicated.Should the device or additional information be received, the complaint will be reopened.No further investigation is warranted at this time; however, we will continue to monitor future complaints and investigate as necessary.This investigation is considered closed.

• Brand Name: ORTHOMATCH MOD PS FEM IMPLANT IMPACTOR
• 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 ; 1450 brooks rd.; memphis, TN 38116 ; 5123913905
• MDR Report Key: 22900995
• Report Number: 1020279-2025-01459
• Device Sequence Number: 15725655
• Product Code: JWH
• UDI-Device Identifier: 00885556583784
• UDI-Public: 885556583784
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K142807
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 07/07/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 71442193
• Device Lot Number: 18LBG0085
• 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: 08/07/2025
• Supplement Date Received by Manufacturer: 09/25/2025; 06/12/2026
• Initial Report FDA Received Date: 08/26/2025
• Supplement Report FDA Received Date: 10/01/2025; 07/07/2026
• Date Device Manufactured: 04/11/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Sex: Female