NA 201-23-13Recalls & reported problems
Exactech, Inc. · TIBIAL INSERT TRIAL SZ 3 13 MM · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10885862042248), received between May 9, 2022 and May 9, 2022 — classified as 1 injury.
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 18, 2026.
Most reported problems
Device problems
- Break1
Patient problems
- Failure of Implant1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 9, 2022Break; Break
AS REPORTED, APPROXIMATELY TWELVE YEARS POST LEFT TKA, THE (B)(6) FEMALE PATIENT'S POLY FAILED OVER TIME. DURING SURGERY, A PIECE OF THE TRIAL BROKE OFF BUT WAS RETRIEVED. THERE WERE NO PARTS OR PIECES THAT FELL INTO WOUND SITE. IMPLANT WAS REMOVED AND REPLACED WITH 15MM IMPLANT, BUT WAS DEEMED TOO TIGHT SO IT WAS REMOVED AND DOWNSIZED TO A 13MM PS POLY IMPLANT. THERE WAS NO SURGICAL DELAY/PROLONGATION. PATIENT DEEMED STABLE. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. PROVIDED IMAGES SHOW THE TIBIAL INSERT HAS FRACTURED.
Patient problems: Failure of Implant
MAUDE report 14342011 ↗
Other TEMPLATE devices
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- 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
- ATTUNE 2545-00-545Depuy (Ireland) · TEMPLATE1 recall221 reports
- ARTICUL/EZE 2530-91-000Depuy (Ireland) · TEMPLATE271 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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