SELF CENTERINGRecalls & reported problems across all models
Depuy Orthopaedics, Inc. · 29 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 646
- Deaths reported
- 3
- Injuries reported
- 518
- Recalls
- 0
We found 29 models of SELF CENTERING by Depuy Orthopaedics, Inc. in the FDA's device registry (GUDID). Together they are named in 646 adverse event reports in the FDA's MAUDE database, received between Jun 22, 2017 and Sep 14, 2026 — classified as 3 deaths, 518 injuries, 125 malfunctions.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (246 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported SELF CENTERING problems
Device problems
- Device Dislodged or Dislocated246
- Adverse Event Without Identified Device or Use Problem242
- Difficult to Insert60
- Insufficient Device Problem Information38
- Fracture14
- Appropriate Device Problem Term/Code Not Available10
- Fitting Problem10
- Loose or Intermittent Connection5
Patient problems
- Joint Dislocation218
- Unspecified Infection149
- No Code Available135
- Pain88
- No Clinical Signs, Symptoms or Conditions54
- Insufficient Information45
- Not Applicable41
- Joint Laxity35
SELF CENTERING models
29 models, most reported first. Each model has its own page with its reports, recalls and device details.
- SELF CENTERING 1035-45-000Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented84 reports
- SELF CENTERING 1035-44-000Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented60 reports
- SELF CENTERING 1035-46-000Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented58 reports
- SELF CENTERING 1035-47-000Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented49 reports
- SELF CENTERING 1035-50-000Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented45 reports
- SELF CENTERING 1035-48-000Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented1 death43 reports
- SELF CENTERING 1035-40-000Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented33 reports
- SELF CENTERING 1035-42-000Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented33 reports
- SELF CENTERING 1035-52-000Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented33 reports
- SELF CENTERING 1035-43-000Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented31 reports
- SELF CENTERING 1035-51-000Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented26 reports
- SELF CENTERING 1035-53-000Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented26 reports
- SELF CENTERING 1035-54-000Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented25 reports
- SELF CENTERING 1035-55-000Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented25 reports
- SELF CENTERING 1035-49-000Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented24 reports
- SELF CENTERING 1035-56-000Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented15 reports
- SELF CENTERING 1035-41-000Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented2 deaths14 reports
- SELF CENTERING 1035-57-000Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented5 reports
- SELF CENTERING 1035-65-000Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented5 reports
- SELF CENTERING 2057-39-000TEMPLATE3 reports
- SELF CENTERING 1035-39-000Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented1 report
- SELF CENTERING 1035-59-000Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented1 report
- SELF CENTERING 1035-61-000Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented1 report
- SELF CENTERING 1037-43-000Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented1 report
- SELF CENTERING 1037-44-000Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented1 report
- SELF CENTERING 1037-52-000Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented1 report
- SELF CENTERING 2057-40-000TEMPLATE1 report
- SELF CENTERING 2057-52-000TEMPLATE1 report
- SELF CENTERING 2057-54-000TEMPLATE1 report
Recent SELF CENTERING adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 14, 2026Adverse Event Without Identified Device or Use Problem
It was reported that Patient was revised for infected bipolar hip. Head was exchanged.DOI: Unknown.DOR: (b)(6) 2026.Affected Side: Unknown Hip.
Patient problems: Unspecified Infection
MAUDE report 50755947 ↗InjurySep 8, 2026Device Dislodged or Dislocated
Patient problems: Joint Dislocation
MAUDE report 50676043 ↗InjurySep 1, 2026Adverse Event Without Identified Device or Use Problem
It was reported that patient showed signs of infection. Doctor performed an I&D and swapped out the heads for new ones.DOI: UnknownDOR: (b)(6), 2026Affected Side: Right
Patient problems: Unspecified Infection
MAUDE report 50548016 ↗InjuryAug 31, 2026Device Dislodged or Dislocated
Patient problems: Joint Dislocation
MAUDE report 50521473 ↗MalfunctionAug 3, 2026Difficult to Insert
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50118785 ↗InjuryJul 30, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient had infection and needed to have everything removed to place an antibiotic spacer.DOI- (b)(6) 2026.DOR- (b)(6) 2026.Affected side-Right hip.
Patient problems: Unspecified Infection
MAUDE report 50093425 ↗MalfunctionJul 30, 2026Difficult to Insert
It was reported that during implant assembly with a 28 mm head and impaction onto the stem, the surgeon experienced increased movement between the liner and the 28 mm head. Selected a new self-centering head while retaining the 28 mm, and the construct felt more normal and stable. There was no delay. All available information has been disclosed.
Patient problems: Insufficient Information
MAUDE report 50087278 ↗InjuryJul 29, 2026Adverse Event Without Identified Device or Use Problem
It was reported that Bipolar head removed for washout of Right Hip. Surgeon replaced 45 bipolar head and 28+1.5 articuleze head. Bipolar head swapped out as because of potential infected hip. There was no patient complaints.Affected Side: Right Hip.
Patient problems: Unspecified Infection
MAUDE report 50068553 ↗InjuryJul 7, 2026Device Dislodged or Dislocated
IT WAS REPORTED THAT PATIENT DISLOCATED A BIPOLAR AND REVISED TO AN EMPHASIS DUAL MOBILITY. WHEN TRYING TO TAKE THE BIPOLAR HEAD OFF THE STEM, THE STEM WAS DISLODGED. THERE WAS NO FAILURE ON THIS PART OF THE IMPLANT. IT WAS NOTED THE CEMENT USED WAS NOT DEPUYSYNTHES CEMENT. DOI: (B)(6) 2026. DOR: (B)(6) 2026 AFFECTED SIDE: LEFT.
Patient problems: Joint Dislocation
MAUDE report 25735827 ↗InjuryMay 19, 2026Device Dislodged or Dislocated
IT WAS REPORTED THAT BIPOLAR DISLOCATION; REVISED TO A ACETABULAR CUP AND +4/10 LINER NO ALLEGATION AGAINST IMPLANTS. AFFECTED SIDE-LEFT HIP.
Patient problems: Joint Dislocation
MAUDE report 25216835 ↗MalfunctionMay 13, 2026Difficult to Insert
IT WAS REPORTED THAT THE IMPLANT RATTLED WHEN 28MM HEAD WAS PUT IN BUT WHEN IT WAS SWAPPED FOR ANOTHER BIPOLAR HEAD IT SEEMED TO BE FINE WITH THE SAME 28MM HEAD. THE EXACT DATE OF THE EVENT WAS NOT REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Patient problems: Insufficient Information
MAUDE report 25159850 ↗InjuryMay 12, 2026Device Dislodged or Dislocated
IT WAS REPORTED THAT HH REVISION DUE TO DISLOCATION. AFFECTED SIDE: LEFT HIP.
Patient problems: Joint Dislocation; Joint Laxity
MAUDE report 25149445 ↗InjuryMay 11, 2026Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT'S BIPOLAR DISLOCATED, SO THE SURGEON PUT IN A CONSTRAINED LINER. DOI: (B)(6) 2025, DOR: (B)(6) 2026, AFFECTED SIDE: LEFT HIP.
Patient problems: Joint Dislocation
MAUDE report 25138106 ↗InjuryApr 30, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT DEVELOPED A HIP INFECTION. SURGEON WASHED THE HIP OUT AND REPLACED THE HEAD BALL COMPONENTS OF THE HEMI HIP. INFECTION WAS PRESENT. DOI: UNKNOWN. DOR: ON (B)(6) 2026. AFFECTED SIDE: LEFT HIP.
Patient problems: Unspecified Infection
MAUDE report 25052533 ↗InjuryApr 28, 2026Device Dislodged or Dislocated
IT WAS REPORTED THAT PATIENT HAD LEFT HIP DISLOCATION. PREVIOUS INFECTED HIP. EXPLANTED STEM, BIPOLAR HEAD AND 28+6 SROM HEAD. IMPLANTED SROM STEM WENT UP TO A +12. DOWNSIZED BIPOLAR HEAD TO 43X28. IMPLANTED 28+3 SROM HEAD.
Patient problems: Joint Dislocation
MAUDE report 25013341 ↗
Other Depuy Orthopaedics, Inc. products
- PINNACLE ALTRX98 models · 5,631 reports
- BIOLOX DELTA40 models · 4,995 reports · 1 recall
- PINNACLE182 models · 4,587 reports
- QUICKSET7 models · 3,790 reports
- PINNACLE POROCOAT38 models · 2,112 reports
- SUMMIT POROCOAT20 models · 1,646 reports
- PINNACLE GRIPTION57 models · 1,608 reports
- DURALOC93 models · 1,262 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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