PROSTALAC 2541-91-320Recalls & reported problems
Depuy Orthopaedics, Inc. · PROSTALAC TRIAL BALL SIZE 32 +1 · Class 1
All models of PROSTALAC (21)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295129660), received between May 31, 2019 and Jul 2, 2026 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Break” (1 report).
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.
Reports received per month
Most reported problems
Device problems
- Break1
- Crack1
- Display Difficult to Read1
- Material Deformation1
- Material Twisted/Bent1
- Naturally Worn1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 2, 2026Crack; Material Deformation
IT WAS REPORTED THE PROSTALAC HEAD IS CRACKED AND STRIPPED AND NEEDS TO BE REPLACED. IT WAS NOTED THE DEVICE IS STILL IN ONE PIECE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25690433 ↗MalfunctionNov 1, 2023Break; Naturally Worn; Break; Naturally Worn
THIS EVENT DIDN'T HAPPEN IN SURGERY. HEAD TRIAL HAD A CHIP MISSING OUT OF IT AND WAS VERY WORN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18046055 ↗MalfunctionMay 31, 2019Display Difficult to Read; Material Twisted/Bent; Display Difficult to Read; Material Twisted/Bent
IT WAS REPORTED THAT THE TRIAL IS WORN AND UNABLE TO SEE THE DIAMETER AND LENGTH ON DESCRIPTION. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8659776 ↗
Other TEMPLATE devices
- ATTUNE 2544-01-014Depuy (Ireland) · TEMPLATE802 reports
- ATTUNE 2545-00-546Depuy (Ireland) · TEMPLATE1 recall301 reports
- ARTICUL/EZE 2531-51-000Depuy (Ireland) · TEMPLATE323 reports
- DELTA XTEND 2307-95-000Depuy (Ireland) · TEMPLATE315 reports
- ATTUNE 2545-00-547Depuy (Ireland) · TEMPLATE1 recall231 reports
- ATTUNE 2544-00-520Depuy (Ireland) · TEMPLATE279 reports
- ARTICUL/EZE 2530-91-000Depuy (Ireland) · TEMPLATE271 reports
- ATTUNE 2545-00-545Depuy (Ireland) · TEMPLATE1 recall221 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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