Triathlon 5630-G-328Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613327015980), received between Oct 10, 2019 and Oct 14, 2019 — classified as 4 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (4 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.

• InjuryOct 14, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  THIS PI IS FOR PAIN AND DRAINAGE OF THE PATIENT'S RIGHT KNEE ON (B)(6) 2017. IN PERFORMING A MEDICAL REVIEW FOR THE REVISION OF THE PATIENT'S RIGHT KNEE ON (B)(6) 2017 , THE FOLLOWING FINDINGS WERE REPORTED. ON (B)(6) 2017: ¿PROBLEMS STARTING EARLY AFTER SURGERY,¿ RESIDUAL HEMARTHROSIS, ASPIRATION 3 TIMES, 50-ML BLOOD REPORTEDLY REMOVED. ON (B)(6) 2017: MANIPULATION UNDER ANESTHESIA ON (B)(6) 2017: PAIN, CATCHING ON LATERAL SIDE OF KNEE, DRAINAGE PERFORMED (25-ML), NO INFECTION. ON (B)(6) 2017: PERSISTENT PAIN WITH RECURRENT EFFUSIONS. 30-ML DRAINED, NO INFECTION.

  Patient problems: Pain

  MAUDE report 9185921 ↗
• InjuryOct 14, 2019Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  THIS PI IS FOR THE ASPIRATION OF THE PATIENT'S RIGHT KNEE ON (B)(6) 2017. IN PERFORMING A MEDICAL REVIEW FOR THE REVISION OF THE PATIENT'S RIGHT KNEE ON (B)(6) 2017, THE FOLLOWING FINDINGS WERE REPORTED. ON (B)(6) 2017: ¿PROBLEMS STARTING EARLY AFTER SURGERY,¿ RESIDUAL HEMARTHROSIS, ASPIRATION 3 TIMES, 50-ML BLOOD REPORTEDLY REMOVED. ON (B)(6) 2017: MANIPULATION UNDER ANESTHESIA ON (B)(6) 2017: PAIN, CATCHING ON LATERAL SIDE OF KNEE, DRAINAGE PERFORMED (25-ML), NO INFECTION. ON (B)(6) 2017: PERSISTENT PAIN WITH RECURRENT EFFUSIONS. 30-ML DRAINED, NO INFECTION.

  Patient problems: Aspiration/Inhalation; Injury; Swelling

  MAUDE report 9185908 ↗
• InjuryOct 10, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  THIS PI IS FOR PERSISTENT PAIN AND DRAINAGE PROCEDURE ON (B)(6) 2017. IN PERFORMING A MEDICAL REVIEW FOR THE REVISION OF THE PATIENT'S RIGHT KNEE ON (B)(6) 2017, THE FOLLOWING FINDINGS WERE REPORTED. IN (B)(6) 2017: ¿PROBLEMS STARTING EARLY AFTER SURGERY,¿ RESIDUAL HEMARTHROSIS, ASPIRATION 3 TIMES, 50-ML BLOOD REPORTEDLY REMOVED. IN (B)(6) 2017: MANIPULATION UNDER ANESTHESIA. IN (B)(6) 2017: PAIN, CATCHING ON LATERAL SIDE OF KNEE, DRAINAGE PERFORMED (25-ML), NO INFECTION. IN (B)(6) 2017: PERSISTENT PAIN WITH RECURRENT EFFUSIONS. 30-ML DRAINED, NO INFECTION.

  Patient problems: Injury; Pain

  MAUDE report 9174954 ↗
• InjuryOct 10, 2019Insufficient Device Problem Information; Patient Device Interaction Problem; Insufficient Device Problem Information; Patient Device Interaction Problem

  THIS PI IS FOR THE MANIPULATION UNDER ANESTHESIA OF PATIENT'S RIGHT KNEE (B)(6) 2017. IN PERFORMING A MEDICAL REVIEW FOR THE REVISION OF THE PATIENT'S RIGHT KNEE ON (B)(6) 2017, THE FOLLOWING FINDINGS WERE REPORTED. ON (B)(6)2017: ¿PROBLEMS STARTING EARLY AFTER SURGERY,¿ RESIDUAL HEMARTHROSIS, ASPIRATION 3 TIMES, 50-ML BLOOD REPORTEDLY REMOVED. ON (B)(6)2017: MANIPULATION UNDER ANESTHESIA. ON (B)(6)2017: PAIN, CATCHING ON LATERAL SIDE OF KNEE, DRAINAGE PERFORMED (25-ML), NO INFECTION. ON (B)(6)2017: PERSISTENT PAIN WITH RECURRENT EFFUSIONS. 30-ML DRAINED, NO INFECTION.

  Patient problems: Injury; Scar Tissue

  MAUDE report 9174569 ↗

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