MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REF SPHER HEAD SCREW 30MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU

Catalog Number	71332530
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	01/26/2026
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 patient complication related to a product problem with a smith+nephew device.The reported issue(s) relate to known risks with the device itself or with its use 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, during a redapt fully porous cup surgery, one (1) ref spher head screw 30mm had gone beyond the screw hole and lower than the petals of one (1) redapt fully porous shell 58mm, therefore the cancellous screw was removed with some difficulty.Surgeon decided to not replace the screw, therefore, leaving a void in patient's bone.The procedure was resumed, after a non-significant delay, using the same device.No further complications were reported.
Additional Manufacturer Narrative
H11: internal complaint reference (b)(4).H2: additional information: d10: concomitant devices.H3, h6: the devices were not returned for evaluation; therefore, a device analysis could not be performed.The images provided do not aid in the evaluation of the reported device.A review of the productions orders did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history for the part numbers over the past 12 months and for the batch numbers based on historical data of the device did not reveal similar events for the listed device.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 products and event.According with the inspection drawings, the final inspection includes the verification of parts configuration per print.According with the surgical technique, the acetabular screw insertion section states that for fixation, each screw hole must be predrilled and aligned using the drill guide.After drilling, the screw is introduced and secured with the appropriate instruments, ensuring it is fully seated within the screw hole.Each hole can accept a spherical head screw.Proper seating prevents the screw from impinging on the acetabular shell, maintaining correct positioning and stability.Make sure the screw is fully seated so that it will not interfere with the redapt fully porous shell.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 insertion technique.Based on this investigation, the need for corrective action is not indicated.Should the devices 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.

• Brand Name: REF SPHER HEAD SCREW 30MM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU
• 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: 24341241
• Report Number: 1020279-2026-00223
• Device Sequence Number: 8319121
• Product Code: MEH
• UDI-Device Identifier: 03596010460479
• UDI-Public: 3596010460479
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K990666
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/16/2026

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: 71332530
• Device Lot Number: 25EM05296
• 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: 01/26/2026
• Supplement Date Received by Manufacturer: 04/06/2026
• Initial Report FDA Received Date: 02/14/2026
• Supplement Report FDA Received Date: 04/16/2026
• Date Device Manufactured: 05/13/2025
• 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: FLEXIBLE DRILL 35 MM (PN: 71362935, LN: 25BSC0002); REDAPT FULLY POROUS (PN: 71354234, LN: 20BM11133)
• Patient Sex: Unknown