MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT PSL HA CLUSTER 50MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	542-11-50E
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Codes	Pain (1994); Injury (2348)
Date of Event	06/05/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.The following devices were also listed in this report: 6.5 cancellous bone screw 40mme; cat# 2030-6540-1; lot# jp6v1m, 6.5 cancellous bone screw 30mm; cat# 2030-6530-1; lot# ey46w8, trident 10° x3 insert 36mm id; cat# 623-10-36e; lot# 7x766r, delta v-40 ceramic head 36/+7,5; cat# 6570-0-736; lot# 52316704.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.
Event or Problem Description
This pi is for the revision of the patient's left hip on (b)(6) 2019.Procedure: the patient underwent left hip replacement (b)(6) 2013.The patient underwent failed left total hip revision, femoral component grossly loosened and removed (b)(6) 2015.Patient had severe pain and dysfunction and mechanical complication of previous left total hip revision.All components exchanged except femur on (b)(6) 2019.

• Brand Name: TRIDENT PSL HA CLUSTER 50MM
• 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: 9208550
• Report Number: 0002249697-2019-03541
• Device Sequence Number: 3032142
• Product Code: LPH
• UDI-Device Identifier: 07613327037265
• UDI-Public: 07613327037265
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K143085
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/18/2019

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 Catalogue Number: 542-11-50E
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/20/2019
• Initial Report FDA Received Date: 10/18/2019
• 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: 62 YR
• Patient Weight: 82