MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT PSL HA CLUSTER 54MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	542-11-54F
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/21/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
Primary procedure, left hip.It was reported that when the outer sterile blister was opened, what appeared to be a hair was inside.Due to sterility concerns, the inner sterile blister was not opened and the device was not used.Another device was obtained and used.Surgery was completed successfully with a surgical delay of approximately 1-2 minutes.Device and packaging is available for return.Otherwise, no further information will be available.
Additional Manufacturer Narrative
An event regarding foreign matter involving a trident shell was reported.The event was confirmed.Method & results: -device evaluation and results: the device was returned along with the packaging box, outer blister, inner blister with implant sticker and ifu.Alleged foreign matter (hair) was found inside the outer blister tray.-medical records received and evaluation: no medical records or x-rays were made available for evaluation.-device history review: device history review indicated the devices accepted into final stock from the reported lot were free from discrepancies.-complaint history review: there has been no other event for the lot referenced.Conclusions: the reported event for the foreign matter (hair) was confirmed based on the returned product packaging.However, a root cause could not be determined based on the consultation with packaging sme indicating the device was returned already opened.There is no indication that the foreign matter happened during packaging process.A review of the device history indicated no reported discrepancies were reported.No further investigation is needed at this time.If additional information are received, this investigation will be reopened and re-evaluated.
Event or Problem Description
Primary procedure, left hip.It was reported that when the outer sterile blister was opened, what appeared to be a hair was inside.Due to sterility concerns, the inner sterile blister was not opened and the device was not used.Another device was obtained and used.Surgery was completed successfully with a surgical delay of approximately 1-2 minutes.Device and packaging is available for return.Otherwise, no further information will be available.

• Brand Name: TRIDENT PSL HA CLUSTER 54MM
• 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: 8703573
• Report Number: 0002249697-2019-02265
• Device Sequence Number: 11218123
• Product Code: LPH
• UDI-Device Identifier: 07613327037203
• UDI-Public: 07613327037203
• Combination Product (Y/N): N
• Initial Reporter State: WY
• Initial Reporter Country: US
• PMA/510(K) Number: K143085
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2024
• Device Catalogue Number: 542-11-54F
• Device Lot Number: DP15WP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2019
• Initial Date Received by Manufacturer: 05/21/2019
• Supplement Date Received by Manufacturer: 06/28/2019
• Initial Report FDA Received Date: 06/17/2019
• Supplement Report FDA Received Date: 07/26/2019
• 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
• Patient Age: 80 YR