MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH NRG KNEE P/S NRG BEARING INSERT SIZE; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number 82-3-0510

Device Problems Out-Of-Box Failure (2311); Material Integrity Problem (2978); Packaging Problem (3007)

Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)

Event Date 04/24/2017

Event Type  malfunction  

Manufacturer Narrative

A supplemental report will be submitted upon completion of the investigation.

Event Description

During the surgery when opening the outer packing, personal found that the plastic packaging had a inflatable deformation but the outer packing was in good condition.The products were not used.Instead surgeon used the same number of 8 mm gasket to complete the operation.

Manufacturer Narrative

An event regarding damaged inner packaging involving a scorpio insert was reported.The event was confirmed.Method & results: visual inspection was initially carried out on the part via the photographs of the affected parts supplied, the inner blister packaging appeared to have been deformed likely as a result of heat damage.The returned part confirmed the issue already identified via the photographs of the affected parts supplied medical records received and evaluation: not performed, no patient history was provided and no adverse consequences to the patient were noted.Device history review: review indicated all devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there have been 1 other events for the lot referenced.An nc was opened to address this issue.Conclusions: the reported event was confirmed via the photographs of the affected part.An nc has been opened to address the observed non-conformance and concluded, " deformity to the inner packaging involving a scorpio insert occurred during distribution." if additional information become available, this investigation will be reopened.

Event Description

During the surgery when opening the outer packing, personal found that the plastic packaging had a inflatable deformation but the outer packing was in good condition.The products were not used.Instead surgeon used the same number of 8 mm gasket to complete the operation.

• Brand Name: NRG KNEE P/S NRG BEARING INSERT SIZE
• 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-CORK; ida industrial estate; carrigtwohill NA
• Manufacturer Contact: cindy chuhinko ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6583590
• MDR Text Key: 75816027
• Report Number: 0002249697-2017-01604
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: CN
• PMA/PMN Number: K030978
• 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: 07/06/2017

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: 03/31/2019
• Device Catalogue Number: 82-3-0510
• Device Lot Number: 47210601
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/25/2017
• Initial Date FDA Received: 05/22/2017
• Supplement Dates Manufacturer Received: 06/09/2017
• Supplement Dates FDA Received: 07/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/19/2014
• 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