MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT PSL HA CLUSTER 56MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	542-11-56F
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Fall (1848); Bone Fracture(s) (1870); Pain (1994)
Date of Event	03/16/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.Review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.
Event or Problem Description
Patient stated he fell down a flight of stairs.Surgeon broke patient pelvic bone during left hip surgery during implantation.Patient says his femur and tailbone hurt but x-rays look fine.
Additional Manufacturer Narrative
An event regarding intraoperative fracture involving an trident shell was reported.The event was not confirmed.Method & results: device evaluation and results: could not be performed as no items associated with the event were returned for evaluation.Medical records received and evaluation: the provided medical information was submitted to a consulting clinician who indicated "based upon the operative report description of a ¿small posterior crack not propagating¿ in the acetabulum and the use of three screws and a stable construct, there is no evidence that any complication resulted from the primary left total hip arthroplasty surgery.There is no indication that factors of faulty component design, manufacturing or materials are present in this case." device history review: confirmed all devices accepted into finished goods conformed to specification.Complaint history review: a complaint history review confirmed no other similar events for the reported lot.Conclusions: the event could not be confirmed nor the root cause determined because the devices were not returned for evaluation and insufficient medical information was provided.The provided medical information was submitted to a consulting clinician who indicated that based upon the operative report description of a ¿small posterior crack not propagating¿ in the acetabulum and the use of three screws and a stable construct, there is no evidence that any complication resulted from the primary left total hip arthroplasty surgery.There is no indication that factors of faulty component design, manufacturing or materials are present in this case.Also as per product recall verification response it is confirmed that none of the reported devices were part of the recall.If the devices and/or additional information are received, this investigation will be reopened and re-evaluated.
Event or Problem Description
Patient stated he fell down a flight of stairs.Surgeon broke patient pelvic bone during left hip surgery during implantation.Patient says his femur and tailbone hurt but x-rays look fine.

• Brand Name: TRIDENT PSL HA CLUSTER 56MM
• 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: 6487063
• Report Number: 0002249697-2017-01226
• Device Sequence Number: 1199199
• Product Code: LPH
• UDI-Device Identifier: 07613327037227
• UDI-Public: (01)07613327037227(11)151119(17)211130(10)H64303
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K143085
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/28/2017

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: 11/30/2020
• Device Model Number: 542-11-56F
• Device Catalogue Number: 542-11-56F
• Device Lot Number: H64303
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/16/2017
• Supplement Date Received by Manufacturer: 06/28/2017
• Initial Report FDA Received Date: 04/12/2017
• Supplement Report FDA Received Date: 07/28/2017
• 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: 67 YR
• Patient Weight: 76