MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT PSL HA SOLID BACK 50MM; IMPLANT

Catalog Number 540-11-50E

Device Problem Component Missing (2306)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/07/2014

Event Type  malfunction  

Event Description

The sales rep, has reported on behalf of the customer that four 50mm trident psl cup from the same lot number have been used in separate surgeries and each of the four implants have allegedly been missing the dome hole plug.The sales rep has reported that all four surgeries were completed successfully and there were no adverse affects to the patients.The sales rep has reported that additional bone plug implants were immediately available to complete the surgery.

Manufacturer Narrative

An event regarding a missing dome hole plug from trident shell device packaging was reported.The event was not confirmed.Device evaluation and results: not performed as the reported device and packaging was not returned for evaluation.Medical records received and evaluation: not performed as no adverse consequences to the patient were reported.Device history review: review indicated all devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review:there has been three other events for the lot referenced.The reported trident shell was implanted successfully and there were no adverse affects to the patient.The sales rep has reported that additional bone plug implants were immediately available to complete the surgery.The returned packaging was not returned, hence it could not be confirmed if the dome hole plug was missing from the packaging.One unit from the same lot (lot: 49073501) was found to be available in mahwah fg.The device packaging was opened in mahwah and it was confirmed that no dome hole plug was present within the packaging.(b)(4).

• Brand Name: TRIDENT PSL HA SOLID BACK 50MM
• Type of Device: IMPLANT
• 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: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4309701
• MDR Text Key: 5132070
• Report Number: 0002249697-2014-04544
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K983382
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2019
• Device Catalogue Number: 540-11-50E
• Device Lot Number: 49073501
• Other Device ID Number: STERILE LOT 1409BCA
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/10/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2014
• 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