DJO SURGICAL 940-02-58HRecalls & reported problems
Encore Medical, L.P. · EMPOWR Acet System, Cup, Hemispherical, Cluster Hole, 58mm · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 13
- Deaths reported
- 0
- Injuries reported
- 13
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00190446311591), received between Jun 15, 2021 and Jul 29, 2026 — classified as 13 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).
5 other recalls cover devices cleared under the same FDA submission (K190057); 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem9
- Appropriate Device Problem Term/Code Not Available1
- Device Dislodged or Dislocated1
- Positioning Problem1
- Unstable1
Patient problems
- Joint Laxity4
- Joint Dislocation3
- Insufficient Information2
- No Clinical Signs, Symptoms or Conditions2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Failure of Implant1
Recent adverse event reports
The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.
InjuryJul 29, 2026Unstable
InjuryMay 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryApr 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryAug 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryFeb 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - MEDIAL WALL OF ACET. COLLAPSED.
Patient problems: Failure of Implant
MAUDE report 18785244 ↗InjuryDec 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - MDR - DISLOCATION - PATIENT DISLOCATED AFTER TIME DUE TO CUP POSITION.
Patient problems: Joint Dislocation
MAUDE report 18280047 ↗InjuryNov 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - SURGEON TOOK OUT THE CUP, LINER AND HEADBALL TO PUT IN A ZIMMER DUAL MOBILITY BUT USED DJO 28MM CERAMIC HEAD TO MATCH THE STEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18218201 ↗InjuryJun 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJun 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryOct 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - ACETABULAR CUP PERFORATED MEDIAL WALL OF PELVIS POST OPERATIVE LIT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15670575 ↗InjuryMay 18, 2022Positioning Problem
REVISION SURGERY - EMPOWR CUP WAS NOT FIXATED WELL. CUP HASN'T ROTATED RETROVENTED AND VENTICAL. LINER, HEAD, CUP REMOVED. EMPOWR CUP AND CONSTRAINED IMPLANTED.
Patient problems: Insufficient Information
MAUDE report 14429916 ↗InjuryApr 12, 2022Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO SOFT TISSUE ISSUES.
Patient problems: Insufficient Information
MAUDE report 14086036 ↗InjuryJun 15, 2021Device Dislodged or Dislocated
REVISION SURGERY - PATIENT DISLOCATING, NO TRAUMA INVOLVED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 12005612 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K190057. One submission often covers many models, so check the product and lot details in each record.
- Z-1234-2026 · Jan 5, 2026 · Open, ClassifiedEMPOWR Acetabular System: Liner, 10 degree Hooded, HXe+, 36H, REF: 942-01-36H; Liner, 10 degree Hooded, HXe+, 36J, REF: 942-01-36J; Liner, 10 degree Hooded, HXe+, 40G, REF: 942-01
- Z-0103-2024 · Aug 22, 2023 · Open, ClassifiedEMPOWR Acetabular System, Liner, 10 Hooded, HXe+, 40H, REF: 942-01-40H
- Z-0125-2023 · Aug 12, 2022 · Open, ClassifiedEMPOWR Acetabular System, Liner, 10 deg Hooded, HXe+ 40H, REF: 942-01-40H. Orthopedic implant component.
- Z-0135-2021 · Sep 9, 2020 · Open, ClassifiedEMPOWR Acetabular System *** EMPOWR Acetabular Cup, Cluster Hole, 54G *** Size 54G 54 mm Dia./Cluster Hole Alpha Code G Liner P2 Porous Coated REF 940-02-54G - Product Usage: are
- Z-1929-2020 · Oct 22, 2019 · Open, ClassifiedEMPOWR Acetabular System, Non-Sterile, Model Numbers 803-15-023 803-15-026 803-15-027 803-15-028 803-15-029 803-15-030 Product Usage: The EMPOWR Acetabular Impactor Balls is int
Other Hip Prosthesis, semi-constrained, cemented, metal/polymer, + additive, porous, uncemented devices
- DJO SURGICAL 942-01-40HEncore Medical, L.P. · Hip Prosthesis, semi-constrained, cemented, metal/polymer, + additive, porous, uncemented2 recalls23 reports
- Vivacit-E® 110031012Zimmer, Inc. · Hip Prosthesis, semi-constrained, cemented, metal/polymer, + additive, porous, uncemented1 recall33 reports
- G7® Dual Mobility Acetabular System 110024462Biomet Orthopedics, LLC · Hip Prosthesis, semi-constrained, cemented, metal/polymer, + additive, porous, uncemented1 recall22 reports
- DJO SURGICAL 942-01-36HEncore Medical, L.P. · Hip Prosthesis, semi-constrained, cemented, metal/polymer, + additive, porous, uncemented1 recall5 reports
- DJO SURGICAL 942-01-36JEncore Medical, L.P. · Hip Prosthesis, semi-constrained, cemented, metal/polymer, + additive, porous, uncemented1 recall1 report
- DJO SURGICAL 942-01-32CEncore Medical, L.P. · Hip Prosthesis, semi-constrained, cemented, metal/polymer, + additive, porous, uncemented1 recall0 reports
- TAPERLOC COMPLETE XR 123 MICRO FEMORAL 51-145150Biomet Orthopedics, LLC · Hip Prosthesis, semi-constrained, cemented, metal/polymer, + additive, porous, uncemented46 reports
- TAPERLOC COMPLETE MICRO PRIMARY FEMORAL 51-106160Biomet Orthopedics, LLC · Hip Prosthesis, semi-constrained, cemented, metal/polymer, + additive, porous, uncemented35 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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