Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SPECIALTY TRIATHLON CR TIBIAL INSERT TRIAL SIZE 7 13MM; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

STRYKER ORTHOPAEDICS-MAHWAH SPECIALTY TRIATHLON CR TIBIAL INSERT TRIAL SIZE 7 13MM; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER Back to Search Results
Catalog Number I-K34960713
Device Problems Difficult to Insert (1316); Difficult to Remove (1528)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/01/2019
Event Type  malfunction  
Manufacturer Narrative
It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.
 
Event Description
It was reported that during a knee procedure, the insert trials were difficult to engage into the baseplate trial, and then were very difficult to release.Post-op, the insert trials were tested with several other baseplate trials and exhibited the same behavior.Surgery was completed successfully with no delay.The insert trials are available for return, and the rep reported no further information is available.
 
Manufacturer Narrative
An event regarding alleged "assembly issue" involving a specialty trial was reported.The event was not confirmed.Method & results: device evaluation and results: examination of the returned device with engineer indicated damage observed on the posterior aspect consistent with contact against hard object.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.A functional inspection was performed with the returned device and mated with a tibial template from finished goods (car 6541-2-607, lot s15329304).The complaint device assembled onto the template as intended.There was resistance disassembling both devices but could be from the damage found on the posterior side of the complaint device.Medical records received and evaluation: no medical records or x-rays were made available for evaluation.Device history review: review of the device history records indicates that all devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other events for this lot.Conclusions: the reported event was not confirmed.Examination of the returned device with engineer indicated damage observed on the posterior aspect consistent with contact against hard object.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.A functional inspection was performed with the returned device and mated with a tibial template from finished goods (car 6541-2-607, lot s15329304).The complaint device assembled onto the template as intended.There was a resistance disassembling both devices but could be from the damage found on the posterior side of the complaint device.If additional information are received, this investigation will be reopened and re-evaluated.
 
Event Description
It was reported that during a knee procedure, the insert trials were difficult to engage into the baseplate trial, and then were very difficult to release.Post-op, the insert trials were tested with several other baseplate trials and exhibited the same behavior.Surgery was completed successfully with no delay.The insert trials are available for return, and the rep reported no further information is available.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
SPECIALTY TRIATHLON CR TIBIAL INSERT TRIAL SIZE 7 13MM
Type of Device
PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
Manufacturer (Section D)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
MDR Report Key8466870
MDR Text Key140535643
Report Number0002249697-2019-01483
Device Sequence Number1
Product Code HRY
UDI-Device Identifier07613327305111
UDI-Public07613327305111
Combination Product (y/n)N
PMA/PMN Number
K172326
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other
Type of Report Initial,Followup
Report Date 07/19/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/29/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date02/28/2023
Device Catalogue NumberI-K34960713
Device Lot NumberAP12C52
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/01/2019
Date Manufacturer Received06/24/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
-
-