Triathlon 5630-G-308Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613327015928), received between Jun 17, 2019 and Nov 20, 2019 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K071881, K082567, K203099); 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.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryNov 20, 2019Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  A MEDICAL REVIEW PERFORMED AS PART OF PI IDENTIFIED AN "ARTHROSCOPY OF THE LEFT KNEE" HAD TAKEN PLACE ON (B)(6) 2012. MEDICAL REVIEW STATED: "EARLY POST RIGHT KNEE REPLACEMENT, PATIENT STARTED TO DEVELOP LEFT KNEE COMPLAINTS IN THE PKR, AS REPORTED ON (B)(6) 2012. THERE WAS OCCASIONAL BUT VERY SHARP PAIN IN THE ANTERO-MEDIAL SIDE OF THE KNEE WITH FEELINGS OF GIVING WAY. RANGE OF MOTION (ROM) WAS NORMAL WITH ADEQUATE LIGAMENT STABILITY. X-RAYS DID REPORT NO PATHOLOGICAL CHANGES. BECAUSE PAIN SYMPTOMS DID NOT IMPROVE, AN INDICATION FOR ARTHROSCOPY OF THE LEFT KNEE WAS MADE AND PERFORMED ON (B)(6) 2012. A GENERALISED GRADE-3 OA WAS OBSERVED IN THE PF JOINT AND TROCHLEA (FEMORAL SIDE OF THE PF-JOINT) WITH THE PKR DEVICES WELL _IXED TO THE BONE. THE ACL (ANTERIOR CRUCIATE LIGAMENT) AND LATERAL COMPARTMENT WERE EVALUATED AS INTACT. COMPLAINTS WERE CONCLUDED TO BE CAUSED BY THE PF JOINT PROBLEMS. CONSERVATIVE TREATMENT FOR THE LEFT KNEE WAS INITIATED FOR A WHILE BUT BECAUSE OF LACK OF CLINICAL PROGRESS, A DECISION FOR A LEFT KNEE REVISION WAS MADE INDICATED BY DISEASE PROGRESS IN THE PF-JOINT WITH A PLANNED CONVERSION OF THE PKR TO A TOTAL KNEE."

  Patient problems: Injury; Pain

  MAUDE report 9347926 ↗
• InjuryOct 23, 2019Naturally Worn; Naturally Worn

  REVISION OF LEFT KNEE. STRYKER UNI-KNEE TO TOTAL KNEE. REP STATED THAT THIS REVISION MIGHT BE DUE TO "LATERAL SIDE WEAR." REP COULD NOT CONFIRM IF THE WEAR IS SPECIFIC TO THE INSERT.

  Patient problems: Injury

  MAUDE report 9226919 ↗
• InjurySep 5, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  THIS PI IS FOR LEFT KNEE. IT WAS REPORTED THROUGH THE COMMUNICATION OF AN ATTORNEY THAT ALLEGEDLY THE PATIENT WAS REVISED DUE TO A FAILED LEFT UNICOMPARTMENTAL ARTHROPLASTY.

  Patient problems: Injury; Pain

  MAUDE report 8964918 ↗
• MalfunctionJun 17, 2019Difficult to Insert; Difficult to Insert

  PRIMARY PROCEDURE, MANUAL LEFT MEDIAL PKR. IT WAS REPORTED THAT THE POLY WOULD NOT GO IN CORRECTLY TO THE BASEPLATE USING THE TIBIAL IMPACTOR (CATALOG 5650-4-812). ANOTHER DEVICE OF THE SAME CATALOG BUT DIFFERENT LOT WAS OBTAINED AND PERFORMED CORRECTLY. SURGERY WAS COMPLETED SUCCESSFULLY WITH A DELAY OF APPROXIMATELY 1 MINUTE WHILE A TOURNIQUET WAS BEING USED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8703425 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K071881, K082567, K203099. One submission often covers many models, so check the product and lot details in each record.

• Z-0869-2009 · Nov 25, 2008 · Terminated
  Triathlon PKR Insert X3 #1 LM/RL - 8mm, 5630-G-108, Lot code NXDMEE Triathlon PKR Insert X3 #1 RM/LL - 12mm, 5630-G-122, Lot Code M8JMEE Intended Use: - Moderately disabling