MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT PSL HA CLUSTER 48MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	542-11-48D
Medical Device Problem Codes	Malposition of Device (2616); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Pain (1994)
Date of Event	06/30/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the device history records indicate no relevant reported discrepancies.There have been no other similar events for the lot referenced.It was noted that the device is not available for evaluation.Additional information has been requested and if received, will be provided in the supplemental report upon completion of the investigation.
Event or Problem Description
On (b)(6) 2017, tha was done with trident ha cup, x3 liner, v40 head, cancellous screw, accolade stem and the patient was discharged the hospital 4 weeks after operation.A fracture line was confirmed at post op x-p, however, it was not confirmed and the bone around screw became hollowed out at current x-p.After discharged the hospital the patient felt the pain at operative area, which continued.
Additional Manufacturer Narrative
An event regarding a periprosthetic fracture four weeks following a total hip arthoplasty involving a trident shell was reported.The event was confirmed.It was also noted through the medical review that the shell was malpositioned.Conclusions: a medical review was performed and concluded that "an adverse mix of patient-related (osteoporosis and acetabular dysplasia) and procedure-related factors (surgical preparation in osteoporotic bone) have caused a periprosthetic fracture of the acetabulum without dislocation allowing conservative treatment without revision surgery required." there was no evidence of a device related issue on review of the medical review.No further investigation for this event is possible at this time.If additional information and/or device become available, this investigation will be reopened.
Event or Problem Description
On (b)(6) 2017, tha was done with trident ha cup, x3 liner, v40 head, cancellous screw, accolade stem and the patient was discharged the hospital 4 weeks after operation.A fracture line was confirmed at post op x-p, however, it was not confirmed and the bone around screw became hollowed out at current x-p.After discharged the hospital the patient felt the pain at operative area, which continued.

• Brand Name: TRIDENT PSL HA CLUSTER 48MM
• 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: 6749044
• Report Number: 0002249697-2017-02326
• Device Sequence Number: 210235
• Product Code: LPH
• UDI-Device Identifier: 07613327037180
• UDI-Public: 07613327037180
• Combination Product (Y/N): N
• PMA/510(K) Number: K143085
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/28/2017

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: 11/18/2021
• Device Catalogue Number: 542-11-48D
• Device Lot Number: 57567704
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/30/2017
• Supplement Date Received by Manufacturer: 08/30/2017
• Initial Report FDA Received Date: 07/27/2017
• Supplement Report FDA Received Date: 09/28/2017
• 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
• Patient Age: 63 YR
• Patient Weight: 47