MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SYN TPRD RMR SZ 8-9-10; PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL

Catalog Number	71366209
Medical Device Problem Codes	Degraded (1153); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H11: internal complaint reference: case (b(4).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.The other devices used in the surgery are: 1x 71366211 2x 71366213 1x 71366217 1x unknown synergy hip instrument.
Event or Problem Description
It was reported that, during a thr surgery, the implant sits above desired depth due to woken syn tprd rmr (sz 8-9-10-11-12-17-18, two (2) sz 13-14) and an unknown synergy hip instrument.The surgery was completed, after a significant delay, with the same reported devices.The current health status of the patient is unknown.
Event or Problem Description
It was reported that, during a thr surgery, the implant sits above desired depth due to five (5) syn tprd rmr (sz 8-18), eleven (11) syn f/t brch (sz 8-18 ) and a femoral canal finder that were worn.The surgery was completed, after a non-significant delay, with the same reported devices.The current health status of the patient is unknown.
Additional Manufacturer Narrative
H10: the information received by the manufacturer has been re-evaluated for mdr reporting and it was determined that this case does not meet the threshold for reporting and is a non-reportable event.Per an additional response from the customer, it was specified that the surgical delay was less than 30 minutes, which changes the reportability to a non-reportable event.If further details are provided confirming the occurrence of a reportable event, our files will be updated accordingly and a further report submitted outlining both the event details and our investigations performed.H2: additional information on: b5 & h6 (medical device problem code).

• Brand Name: SYN TPRD RMR SZ 8-9-10
• Common Device Name: PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, 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: 22121103
• Report Number: 1020279-2025-00983
• Device Sequence Number: 4171852
• Product Code: JDG
• UDI-Device Identifier: 03596010199737
• UDI-Public: 3596010199737
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K123598
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/10/2025

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: 71366209
• Device Lot Number: 04BM00503
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/12/2025
• Supplement Date Received by Manufacturer: 06/25/2025
• Initial Report FDA Received Date: 06/01/2025
• Supplement Report FDA Received Date: 07/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 Sex: Unknown