MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH PATELLA CLAMP; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number 6541-3-600

Device Problems Degraded (1153); Device Operates Differently Than Expected (2913); Material Integrity Problem (2978)

Patient Problems No Patient Involvement (2645); No Information (3190)

Event Date 03/10/2016

Event Type  malfunction  

Manufacturer Narrative

When completed, the investigation results will be submitted in a supplemental report.

Event Description

Products being returned are releasing blue residue.Need replacements.

Manufacturer Narrative

A review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.A review of the complaint history indicates there has been no other event for the lot referenced.Device not returned.The event was confirmed; the device handle was degraded.The damaged device was discovered during inspection; there was no surgical procedure associated with the reported event.This event meets the definition of preventive maintenance; no further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.This event was determined to be under the scope of a capa.Chemical and cytotoxicity tests showed the degraded santoprene is non-toxic.The ability to clean and sterilize the degraded instruments has not been compromised.Not returned.

Event Description

Products being returned are releasing blue residue.Need replacements.

• Brand Name: PATELLA CLAMP
• Type of Device: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: keyla colon ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5541969
• MDR Text Key: 41937106
• Report Number: 0002249697-2016-01028
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123486
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 6541-3-600
• Device Lot Number: CXW01F
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/22/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/19/2004
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other