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

Model Number	542-11-54F
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/12/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Should additional information become available it will be reported in a supplemental report upon completion of the investigation.Review of the device history records indicate devices were manufactured and accepted into final stock on with relevant no reported discrepancies.There have been no other similar events for the lot referenced.Not available.
Event or Problem Description
Our distributor reported that during a surgery the thread length protruding past the dome of the acetabular trial and implant of 54mm, and it was very difficult to implant.Seems that with other size of trial the problem did not occur.
Additional Manufacturer Narrative
Conclusion: the reported event is regarding the cup impactor thread protruding from the shell trial.No allegations were made regarding the trident shell.Based on the provided information, the product reported in this investigation did not contribute to the event and is therefore considered concomitant.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
Our distributor reported that during a surgery the thread length protruding past the dome of the acetabular trial and implant of 54mm, and it was very difficult to implant.Seems that with other size of trial the problem did not occur.

• 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: 6322387
• Report Number: 0002249697-2017-00530
• Device Sequence Number: 694897
• Product Code: LPH
• UDI-Device Identifier: 07613327037203
• UDI-Public: (01)07613327037203(11)161025(17)211031(10)57003101
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K143085
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/27/2017

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: 10/31/2021
• Device Model Number: 542-11-54F
• Device Catalogue Number: 542-11-54F
• Device Lot Number: 57003101
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/16/2017
• Supplement Date Received by Manufacturer: 08/30/2017
• Initial Report FDA Received Date: 02/10/2017
• Supplement Report FDA Received Date: 09/27/2017
• 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