MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT 10° X3 INSERT 32MM ID; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	623-10-32E
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	05/08/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
The customer reported that the when the trident liner was opened in the case, there was black debris, which looked like gravel, visible under the poly layer.Another device was on hand to complete the case.
Additional Manufacturer Narrative
An event regarding foreign matter within the packaging involving a trident liner was reported.The event was confirmed.Method & results: device evaluation and results: a visual inspection of the packaging identified a foreign material within the inner blister.Characteristics of foreign material using stereo microscopy and infrared spectroscopy confirmed the foreign material as entangles cotton fibres.Medical records received and evaluation: not performed as no adverse consequences to the patient were noted.Device history review: review indicated all devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other events for the lot referenced.Conclusions: an nc has been raised to investigate the event.The affected unit has been returned to the manufacturing facility in tullagreen cork for investigation.Outer blister was removed from the carton.Outer blister had not been opened.A continuous seal between tyvek and outer blister was present.Foreign material was visible on inner blister.Upon opening outer blister, it was confirmed foreign material was within the inner blister.Inner blister seal was intact.Foreign material was classified as ¿loose foreign material, comprising of fibres, not consistent with packaging material.Dhr was reviewed.There were no non-conformances or rework identified relating to this product.Samples of the foreign material were sent for chemical analysis to understand the origins of the foreign material.Upon completion of analysis, it was detected that the foreign material was cotton in composition.A review of packaging components within the cleanroom environment was carried out and no components were found to be composed of cotton material.It is probable that this foreign material was introduced as a result of poor gowning techniques.A dda was completed with all cleanroom personnel to raise awareness of the complaint and to highlight the importance of correct gowning.There have been no further complaints associated with this lot.This is considered an isolated event.Based on the above no further containment is necessary.
Event or Problem Description
The customer reported that the when the trident liner was opened in the case, there was black debris, which looked like gravel, visible under the poly layer.Another device was on hand to complete the case.

• Brand Name: TRIDENT 10° X3 INSERT 32MM ID
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 6618664
• Report Number: 0002249697-2017-01791
• Device Sequence Number: 11033446
• Product Code: LPH
• UDI-Device Identifier: 07613327039856
• UDI-Public: (01)07613327039856(11)170309(17)220309(10)59036601
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• PMA/510(K) Number: K033716
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/04/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/09/2022
• Device Model Number: 623-10-32E
• Device Catalogue Number: 623-10-32E
• Device Lot Number: 59036601
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2017
• Initial Date Received by Manufacturer: 05/11/2017
• Supplement Date Received by Manufacturer: 07/14/2017
• Initial Report FDA Received Date: 06/07/2017
• Supplement Report FDA Received Date: 08/04/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other