MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SMALL KRH ALL POLY TIBIA 8MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number 64852108

Device Problems Device Packaging Compromised (2916); Device Contamination with Chemical or Other Material (2944)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 12/03/2016

Event Type  malfunction  

Manufacturer Narrative

An evaluation of the device cannot be performed as the device remained implanted in the patient and was not returned to the manufacturer.Additional information has been requested.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.Device was implanted.

Event Description

During the case, unpacking implant gmrs, they found that those 9 implants were contained with the black dust.Then the physician clean them with betadine and continue the case until finished.

Manufacturer Narrative

An event regarding foreign matter inside the device packaging involving a krh all-poly tibia was reported.The event was confirmed.Method and results: -device evaluation and results: only the inner blister pack without its (b)(6) lid was returned for review.Small dark coloured spots are visible throughout the entire surface of the pack.A photograph of the subject device prior to cleaning and implantation was provided.It shows several dark coloured spots at the central hole of the bearing surface.The mar concluded that black spots reported were confirmed as particles on the inner blister surface.The foreign material was mainly comprised of carbon and oxygen, with relevant spectral identification for wool / fabric material or dried blood.Based on the visual appearance and the brittle nature of the foreign material dried blood is the more plausible identification of the foreign material.-medical records received and evaluation: not performed as no medical records were provided.-device history review: review indicated that the device was manufactured and accepted into final stock with no reported discrepancies.-complaint history review: chr review confirmed that there were no similar events for the reported lot.Conclusions: the material analysis indicated that the foreign material was mainly comprised of carbon and oxygen, with relevant spectral identification for wool / fabric material or dried blood but that, based on the visual appearance and the brittle nature of the foreign material dried blood is the more plausible identification of the foreign material.As only the opened inner blister was returned, it cannot be determined as to when the foreign matter had entered the packaging.It is noted that the surgeon decided to implant the subject device after having cleaned it with betadine; the ifu states to discard all nonsterile or contaminated product.No further investigation for this event is possible at this time.If additional information becomes available, this investigation will be reopened.

Event Description

During the case, unpacking implant gmrs, they found the implant contained with the black dust.Then the physician clean them with betadine and continue the case until finished.

• Brand Name: SMALL KRH ALL POLY TIBIA 8MM
• Type of Device: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-LIMERICK; raheen business park; limerick NA
• Manufacturer Contact: rita intorrella ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6213740
• MDR Text Key: 63611080
• Report Number: 0002249697-2016-04062
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: TH
• PMA/PMN Number: K972863
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/25/2021
• Device Catalogue Number: 64852108
• Device Lot Number: LPTC351
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/03/2016
• Initial Date FDA Received: 12/29/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/25/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other