MATRIX MT2201Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 03596010012302), received between Feb 18, 2020 and Oct 31, 2025 — classified as 16 malfunctions.

The most frequently reported specific device problem is “Break” (10 reports).

29 other recalls cover devices cleared under the same FDA submission (P040033); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 31, 2025Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A THA SURGERY, THE PEG ON THE BOTTOM OF THE MTX CEMENTED CUP X BAR BROKE OFF. IT WOULD NOT ALLOW THE X-BAR TO SIT IN PLACE ON THE IMPACTOR PROPERLY. THE PEG WAS FOUND AND DISCARDED. ALL PIECES WERE ACCOUNTED FOR, NONE WERE LEFT WITHIN THE PATIENTS ANATOMY. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23437919 ↗
• MalfunctionSep 5, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING THR SURGERY, THE PEGS THAT HOLD ONE (1) MTX CEMENTED CUP X BAR INTO THE CUP, BROKE OFF. IT IS UNKNOWN IF PIECES FELL INTO THE PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20151176 ↗
• MalfunctionJun 6, 2023Fracture; Fracture

  IT WAS REPORTED, THAT DURING USE. THE DISTAL FIXATION PIN ON A MTX CEMENTED CUP X BAR BROKE OFF, DUE TO EXCESSIVE FORCE PLACED ON ROD WITH ARM. ADDITIONALLY, NO PIECES FELL INTO THE PATIENT. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH A SMITH AND NEPHEW BACK-UP DEVICE. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17076005 ↗
• MalfunctionJun 8, 2022Break; Break

  IT WAS REPORTED THAT, DURING A THR SURGERY, THE MTX CEMENTED CUP X BAR BROKE AT TIP DUE TO WEAR. NO PIECES FELL INTO PATIENT. THE PROCEDURE WAS COMPLETED, WITHOUT DELAY, USING A S+N BACK UP DEVICE. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14640350 ↗
• MalfunctionMar 20, 2022Break; Break

  IT WAS REPORTED THAT THE PEGS OF THE X-BAR BROKE OFF. AS THIS WAS NOTICED IN A NON-SURGICAL ENVIRONMENT, THERE WAS NOT ANY PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13831769 ↗
• MalfunctionMar 20, 2022Break; Break

  IT WAS REPORTED THAT, DURING A THR SURGERY, THE SMALL PEGS OF THE MTX CEMENTED CUP X BAR THAT LOCK IT IN, BROKE OFF. SURGERY WAS FINISHED, WITHOUT ANY DELAY, WITH THE SAME DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13831766 ↗
• MalfunctionMar 1, 2022Break; Break

  IT WAS REPORTED THAT, THE PIN OF A MTX CEMENTED CUP X BAR BROKE. IT IS UNKNOWN IF THIS WAS NOTICED DURING SURGERY OR NOT, THEREFORE, PATIENT INVOLVEMENT HAD NOT BEEN CONFIRMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13636842 ↗
• MalfunctionFeb 1, 2022Break; Break

  IT WAS REPORTED THAT A MTX CEMENTED CUP X BAR IS BROKEN. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13412861 ↗
• MalfunctionJan 10, 2022Break; Break

  IT WAS REPORTED THAT A MATRIX CEMENTED CUP X BAR IS BROKEN. IT IS UNKNOWN WHETHER THIS PROBLEM WAS NOTICED IN A SURGICAL ENVIRONMENT OR NOT; THEREFORE, PATIENT INVOLVEMENT HAS NOT BEEN CONFIRMED.

  Patient problems: Insufficient Information

  MAUDE report 13214194 ↗
• MalfunctionNov 25, 2021Break; Break

  IT WAS REPORTED THAT DURING SET UP FOR A SURGERY, THE MTX CEMENTED CUP X BAR BROKE. THERE WAS NO SIGNIFICANT DELAY AND THE PROCEDURE WAS FINISHED USING THE SAME DEVICE. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12875253 ↗
• MalfunctionOct 27, 2021Break; Break

  IT WAS REPORTED THAT A MATRIX CEMENTED CUP X BAR WAS FOUND WITH A MISSING PIECE AT THE TIP. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12705968 ↗
• MalfunctionSep 16, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT, THE HOLDING PIN ON A MTX CEMENTED CUP X BAR HAD FALLEN OUT OF THE ROD. AS THIS WAS NOTICED UPON CLEANING AND STERILIZATION ACTIVITIES, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12485566 ↗
• MalfunctionApr 19, 2021Connection Problem; Connection Problem

  IT WAS REPORTED THAT DURING A THR A VERTICAL ALIGNMENT ROD DID NOT HOLD IN PLACE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING THE SAME DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11683771 ↗
• MalfunctionMar 30, 2021Break; Break

  IT WAS REPORTED THAT, THE INSTRUMENTS BROKE DURING SURGERY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A SMITH+NEPHEW BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11593507 ↗
• MalfunctionMar 16, 2020Connection Problem; Connection Problem

  IT WAS REPORTED THAT DURING SURGERY THE X BAR WASN'T ABLE TO SIT INTO THE INSERTER. THERE WAS NO DELAY NOR INJURY REPORTED. THERE WAS NO BACKUP AVAILABLE, IT IS UNKNOWN HOW THE SURGERY WAS COMPLETED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9836252 ↗
• MalfunctionFeb 18, 2020Break; Break

  IT WAS REPORTED THAT DURING SURGERY, THE X BAR WELDING WAS NO LONGER WELDED AND THE HEAD TRIAL IS CRACKED INSIDE. SMITH&NEPHEW BACKUP DEVICE WAS AVAILABLE. THE DEVICE MALFUNCTIONED WITHIN THE PATIENT. ALL PIECES WERE RETRIEVED. NO DELAY. NO INJURY TO PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9720227 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P040033. One submission often covers many models, so check the product and lot details in each record.

• Z-2242-2021 · Jul 14, 2021 · Terminated
  smith&nephew BHR SQUARE HEADED NAIL, REF CATALOG NUMBER 999908. For use during orthopedic surgery.
• Z-2268-2018 · May 11, 2018 · Terminated
  Birmingham Hip Resurfacing Acetabular Cup with Impactor: (a) Size 56 mm, REF 74120156 (b) Size 64 mm, REF 74120164 (c) Size 54 mm, REF 74122154 (d) Size 58 mm, REF 74122158 (e) Siz
• Z-2267-2018 · May 11, 2018 · Terminated
  Birmingham Hip Resurfacing Femoral Head: (a) Size 58 mm, REF 74121158 (b) Size 56 mm, REF 74123156
• Z-2745-2015 · Jun 3, 2015 · Terminated
  Smith & Nephew BIRMINGHAM HIP (TM) RESURFACING FEMORAL HEAD, STERILE R, Rx only, REF Numbers: 74121138 (38 MM), 74123140 (40 MM), 74121142 (42 MM), 74123144 (44 MM), 74121146 (46 M
• Z-2746-2015 · Jun 3, 2015 · Terminated
  Smith & Nephew BIRMINGHAM HIP (TM) RESURFACING ACETABULAR CUP W/IMPACTOR, REF Numbers: 74120144 (44 MM), 74120146 (46 MM), 74122146 (46 MM), 74122148 (48 MM), 74120148 (48 MM), 74
• Z-2747-2015 · Jun 3, 2015 · Terminated
  Smith & Nephew BIRMINGHAM HIP (TM) RESURFACING DYSPLASIA CUP W/IMPACTOR, REF Numbers: 74120246 (46 MM), 74122248 (48 MM), 74120250 (50 MM), 74122252 (52 MM), 74120254 (54 MM) Pro
• Z-0029-2008 · Jul 12, 2007 · Terminated
  Smith + Nephew, Birmingham Hip Resurfacing, Dysplasia Cup, 50 mm cup Ref.: 74120250. Hip implant component.
• Z-0016-2008 · Jul 12, 2007 · Terminated
  Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup 46 mm cup Ref.: 74120146. Hip implant component.
• Z-0020-2008 · Jul 12, 2007 · Terminated
  Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 50 mm cup Ref.: 74120150. Hip implant component.
• Z-0028-2008 · Jul 12, 2007 · Terminated
  Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 66 mm cup Ref.: 74120166. Hip implant component.
• Z-0017-2008 · Jul 12, 2007 · Terminated
  Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 44 mm cup Ref.: 74120144. Hip implant component.
• Z-0026-2008 · Jul 12, 2007 · Terminated
  Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 62 mm cup Ref.: 74120162. Hip implant component.
• Z-0030-2008 · Jul 12, 2007 · Terminated
  Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 50 mm cup Ref.: 74120250. Hip implant component.
• Z-0024-2008 · Jul 12, 2007 · Terminated
  Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 58 mm cup Ref.: 74120158. Hip implant component.
• Z-0023-2008 · Jul 12, 2007 · Terminated
  Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 56 mm cup Ref.: 74120156. Hip implant component.

…and 14 more.