MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 3 HOLE ACET SHELL 54MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/CERAMIC/METAL, CEMENTED OR UNCE

Catalog Number	71335554
Medical Device Problem Code	Inaccurate Information (4051)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/10/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a primary hip prosthesis, one (x1) r3 3 hole acet shell 54mm, one (x1) r3 20 deg xlpe acet lnr 36mm x 54mm and one (x1) r3 20 deg xlpe acet lnr 32mm x 54mm were not compatible with the size identified on the packaging, when compared to the corresponding milling tool used for their respective preparation.The surgeon needed to mill a larger size than the one he had initially chosen so that he could complete the procedure without risk or harm to the patient.It is unknown how surgery was completed after a non-significant delay (less than or equal to 30mins).No injury was reported as a consequence of this issue.
Additional Manufacturer Narrative
Internal complaint reference: case: (b)(4).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 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.
Additional Manufacturer Narrative
Additional information: g4.
Event or Problem Description
It was reported that during a primary hip prosthesis, one (x1) r3 3 hole acet shell 54mm, one (x1) r3 20 deg xlpe acet lnr 36mm x 54mm and one (x1) r3 20 deg xlpe acet lnr 32mm x 54mm were not compatible with the size identified on the packaging, when compared to the corresponding milling tool used for their respective preparation.The surgeon needed to mill a larger size than the one he had initially chosen so that he could complete the procedure without risk or harm to the patient.The surgery was completed after a non-significant delay (less than or equal to 30mins) using backup devices.No injury was reported as a consequence of this issue.
Additional Manufacturer Narrative
Internal complaint reference:(b)(4).Additional information: h11: the associated device was returned and evaluated.The visual inspection revealed that it is in its original packaging with the inner trays opened.The device was returned with debris from attempted insertion.A dimensional evaluation performed on the device revealed to be within drawing print specifications.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 for the part number over the past 12 months and for the batch number based on historical data of the device did not reveal similar events for the listed device.A review of the instructions for use documents for total hip systems revealed that the surgeon should be thoroughly familiar with the implants, instruments, and surgical procedure prior to performing surgery.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.According with inspection drawing, the final inspection includes the verification of part configuration per print.Label specification, should match the size specifications according to the packaged device.At this time, we have no evidence to conclude that the product failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include size selected or insertion technique.Based on this investigation, the need for corrective action is not indicated.Should 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.

• Brand Name: R3 3 HOLE ACET SHELL 54MM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/CERAMIC/METAL, CEMENTED OR UNCE
• 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: 20384994
• Report Number: 1020279-2024-02035
• Device Sequence Number: 12764470
• Product Code: MRA
• UDI-Device Identifier: 03596010598257
• UDI-Public: 3596010598257
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K211176
• 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,Followup
• Report Date (Section B): 04/10/2026

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: 71335554
• Device Lot Number: 23LM07390
• 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: 09/17/2024
• Supplement Date Received by Manufacturer: 11/06/2024; Not provided; 04/08/2026
• Initial Report FDA Received Date: 10/07/2024
• Supplement Report FDA Received Date: 11/08/2024; 01/08/2025; 04/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/14/2023
• 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: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PN: 71335754 / LOT: 23KL00106.; PN: 71337654 / LOT: 22LM11988.
• Patient Sex: Unknown