MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT 0 X3 INSERT 36MM ID; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	623-00-36F
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Pain (1994)
Date of Event	02/19/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the device history records indicate devices were manufactured and accepted into final stock with 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.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: tridentii tritanium cluster56f; cat # 702-04-56f; lot # 62711601 delta v-40 ceramic head 36/0; cat # 6570-0-136; lot # 62395303 size 6 accolade ii 127 deg; cat # 6721-0635; lot # 61744901 6.5mm low profile hex screw 35mm; cat # 7030-6535; lot # 95a.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.
Event or Problem Description
Subject reported left thigh pain on (b)(6) 2018.Specifically, subject reported intermittent, persistent thigh pain with unknown etiology.Work up for infection or loosening were negative.Normal appearance on xray, 3-phase bone scan, and mri.Pi reported thigh pain as uncertain to device relation.Subject reported ongoing pain during (b)(6) 2019 office visit.Not a revision.Patient reported thigh pain, implant still in place.
Additional Manufacturer Narrative
Reported event: an event regarding pain involving an trident liner was reported.The event was not confirmed.Method & results: device evaluation and results: visual, dimensional, functional and material analysis could not be performed as the device was not returned.Clinician review: the available medical records were provided to the consulting clinician for a review which was rejected for medical review stating," no imaging studies available for review, no clinical follow-up since 4/1/19 documented.Based upon the information presented, there is no indication that the intermittent, persistent thigh pain described is related to factors associated with the hip implant design, manufacturing or materials, trochanteric bursitis or other soft tissue pathology source should be ruled out." - 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: it was reported that the patient's left hip had thigh pain.The available medical records were provided to the consulting clinician for a review which was rejected for medical review stating that no imaging studies available for review, no clinical follow-up since 4/1/19 documented.Based upon the information presented, there is no indication that the intermittent, persistent thigh pain described is related to factors associated with the hip implant design, manufacturing or materials, trochanteric bursitis or other soft tissue pathology source should be ruled out.The event could not be confirmed nor the root cause be determined because insufficient medical information was provided.Further information such as medical documentation and returned devices are needed.If the devices and/or additional information are received, this investigation will be reopened and re-evaluated.
Event or Problem Description
Subject reported left thigh pain on (b)(6) 2018.Specifically, subject reported intermittent, persistent thigh pain with unknown etiology.Work up for infection or loosening were negative.Normal appearance on xray, 3-phase bone scan, and mri.Pi reported thigh pain as uncertain to device relation.Subject reported ongoing pain during (b)(6) 2019 office visit.Not a revision.Patient reported thigh pain, implant still in place.

• Brand Name: TRIDENT 0 X3 INSERT 36MM ID
• 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: 10179163
• Report Number: 0002249697-2020-01250
• Device Sequence Number: 11533737
• Product Code: LPH
• UDI-Device Identifier: 07613327039535
• UDI-Public: 07613327039535
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K033716
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/07/2020

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: 11/30/2022
• Device Model Number: 623-00-36F
• Device Catalogue Number: 623-00-36F
• Device Lot Number: W507YD
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/04/2020
• Supplement Date Received by Manufacturer: 08/11/2020
• Initial Report FDA Received Date: 06/22/2020
• Supplement Report FDA Received Date: 09/07/2020
• 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: 70 YR
• Patient Weight: 96