MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT PSL HA CLUSTER 46MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	542-11-46D
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Injury (2348)
Date of Event	12/29/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the product history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other events for the lot referenced.It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
Patient had a right total hip replacement (b)(6) 2018.Patient templated to a 46mm cup.During surgery it was noted that the femoral head measured 40mm indicating the magnification in templating was inaccurate.The surgeon reamed to 46 mm which was the smallest cup available.He implanted a 46 cup and he got one screw in the dome.At the time of surgery he was concerned about fixation.He kept the patient touch down weight bearing.She rolled over in bed and dislodged her cup.She was seen in the emergency room and scheduled for surgery.She was revised to a 42mm trident 2 multihole cup with 3 screws.Fixation appeared to be adequate at the time of revision.The patient was stable through the full range of motion.The operation was completed successfully.Surgeon alleges no defect with the implants and said patient factors contributed to the failure.
Event or Problem Description
Patient had a right total hip replacement (b)(6) 2018.Patient templated to a 46mm cup.During surgery it was noted that the femoral head measured 40mm indicating the magnification in templating was inaccurate.The surgeon reamed to 46 mm which was the smallest cup available.He implanted a 46 cup and he got one screw in the dome.At the time of surgery he was concerned about fixation.He kept the patient touch down weight bearing.She rolled over in bed and dislodged her cup.She was seen in the er and scheduled for surgery.She was revised to a 42mm trident 2 multihole cup with 3 screws.Fixation appeared to be adequate at the time of revision.The patient was stable through the full range of motion.The operation was completed successfully.Surgeon alleges no defect with the implants and said patient factors contributed to the failure.
Additional Manufacturer Narrative
Reported event: an event regarding loosening involving a trident shell was reported.A review of the provided x-ray by a clinical consultant confirmed the shell loosening.Method & results: device evaluation and results: not performed as product was not returned.Medical records received and evaluation: the investigation was rejected for medical review however a review of the provided x-ray by a clinical consultant indicated: provided x-ray confirmed the dislodged cup.Need primary/revision operative reports, office/clinical reports, serial x-rays, and examination of the explanted components.Device history review: all devices were manufactured and accepted into final stock with no relevant reported discrepancies.-complaint history review: there have been no other similar events for the reported lot.Conclusion: a review of the provided x-ray by a clinical consultant concluded: provided x-ray confirmed the dislodged cup.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: TRIDENT PSL HA CLUSTER 46MM
• 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: 8272584
• Report Number: 0002249697-2019-00307
• Device Sequence Number: 1557179
• Product Code: LPH
• UDI-Device Identifier: 04546540240460
• UDI-Public: 04546540240460
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K143085
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/01/2019

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2023
• Device Catalogue Number: 542-11-46D
• Device Lot Number: 8Y3E85
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/29/2018
• Supplement Date Received by Manufacturer: 03/04/2019
• Initial Report FDA Received Date: 01/23/2019
• Supplement Report FDA Received Date: 04/01/2019
• 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: Hospitalization; Required Intervention
• Patient Age: 74 YR
• Patient Weight: 79