MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT HEMISPHERICAL CLUSTER HOLE SHELL; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	502-11-52E
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pain (1994); Skin Inflammation/ Irritation (4545)
Date of Event	03/01/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
Patient called stating he had a left tha on or about (b)(6) 2015.Patient has been in constant pain since surgery.Patient says it feels like metal is rubbing on his muscles.Lots of pressure in the hip area.
Event or Problem Description
Patient called stating he had a left tha on or about (b)(6) 2015.Patient has been in constant pain since surgery.Patient says it feels like metal is rubbing on his muscles.Lots of pressure in the hip area.
Additional Manufacturer Narrative
At this time, it cannot be determined if these devices may have caused or contributed to the patient¿s experience.623-00-36e trident 0° x3 insert 36mm id mkk59m 6720-0230 size 2 accolade ii 132 deg 49537001 6570-0-136 delta v-40 ceramic head 36/0 50361703 2030-6540-1 6.5 cancellous bone screw 40mm mmj2x4 an event regarding pain involving an trident shell was reported.The event was not confirmed.Method & results: -device evaluation and results: a visual, functional and dimensional inspection could not be performed as the device was not returned.-medical records received and evaluation: the provided medical information was submitted to a consulting clinician who stated "the primary harm involved is pain following tha.No postoperative clinical records were available for review.Multiple sets of post- tha xrays were reviwed.These all showed a left pressfit tha in good , position, orientation and alignment.The implants appear well fixed without any evidence of loosening.There is evidnce of remodeling of the pevis and greater trochanter from previous surgical intervention.The right hip is noted to have significant deformity due to developmental dysplasia.No obvious cause for the ongoing pain was identified.There is no evidence for defect in the implants or their manufacture." further documentation such as outpatient office/clinic notes would required to aid in the completion of this assessment.-device history review: device history review indicated the devices accepted into final stock from the reported lot were free from discrepancies.-complaint history review: there has been no other event for the lot referenced.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 primary harm involved is pain following tha.The implants appear well fixed without any evidence of loosening.No obvious cause for the ongoing pain was identified.There is no evidence for defect in the implants or their manufacture.Product recall verification response confirmed that none of the reported devices were part of the recall.If the devices and/or additional information such as outpatient office/clinic notes would required to aid in the completion of this assessment.A capa trend analysis was conducted for the reported failure mode and concluded pain may result from other factors not necessarily related to the device.
Additional Manufacturer Narrative
An event regarding pain and patient factors involving a trident shell was reported.The event was not confirmed.Method & results: -product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device remains implanted.-clinician review: a review of the provided medical information by a clinical consultant indicated: "the primary harm involved is pain following tha.No postoperative clinical records were available for review.Multiple sets of post tha x-rayswere reviewed.Thes x-rays all showed a left pressfit tha in good position, orientation and alignment.The implants appear well fixed without any evidence of loosening.There is evidence of remodeling of the pelvis and greater trochanter from previous surgical intervention.The contralateral right hip is noted to have significant deformity due to developmental dysplasia.No obvious cause for the ongoing pain was identified.There is no evidence for defect in the implants or their manufacture.The x-ray recently provided shows similar findings to those recently reviewed.Further documentation which would aid in the completion of this assessment would include: outpatient office/clinic notes" -product history review: review of the device history records indicate 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 lot referenced.Conclusions: it was reported that the patient is experiencing pain and a skin disease post-implantation.A review of the provided medical information by a clinical consultant indicated: "the primary harm involved is pain following tha.No postoperative clinical records were available for review.Multiple sets of post tha x-rayswere reviewed.Thes x-rays all showed a left pressfit tha in good position, orientation and alignment.The implants appear well fixed without any evidence of loosening.There is evidence of remodeling of the pelvis and greater trochanter from previous surgical intervention.The contralateral right hip is noted to have significant deformity due to developmental dysplasia.No obvious cause for the ongoing pain was identified.There is no evidence for defect in the implants or their manufacture.The x-ray recently provided shows similar findings to those recently reviewed.Further documentation which would aid in the completion of this assessment would include: outpatient office/clinic notes" the patient is also inquiring if their implants are part of a recall.Base on the catalog number and lot code provided, the reported device is not subject to a recall.No further investigation for this event is possible at this time.If devices and/or additional information become available to indicate further evaluation is warranted, this record will be reopened.The following devices were also listed in this report: 623-00-36e trident 0° x3 insert 36mm id mkk59m 6720-0230 size 2 accolade ii 132 deg 49537001 6570-0-136 delta v-40 ceramic head 36/0 50361703 2030-6540-1 6.5 cancellous bone screw 40mm mmj2x4 it cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.
Event or Problem Description
Patient called stating he had a left tha on or about (b)(6) 2015.Patient has been in constant pain since surgery.Patient says it feels like metal is rubbing on his muscles.Lots of pressure in the hip area.Update: patient reported having a primary left hip implanted in 2015.Patient reported having ¿metal fragments coming out of body, ¿splinter like¿ to ¿whole shards¿ of metal.Patient noted he has a ¿skin disease¿.Wants to know metal composition of parts.Patient would like to know if implants are subject to a recall.Patient also mentioned, surgeon stated ceramic on metal implant and that x-rays show nothing wrong with implant.

• Brand Name: TRIDENT HEMISPHERICAL CLUSTER HOLE SHELL
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NJ NA ; EI NA
• Manufacturer Contact: brad curtis ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6977723
• Report Number: 0002249697-2017-03105
• Device Sequence Number: 13488073
• Product Code: LPH
• UDI-Device Identifier: 04546540432032
• UDI-Public: 04546540432032
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K143085
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/16/2022
• 2 Devices were Involved in the Event: 1 2

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: 02/29/2020
• Device Model Number: 502-11-52E
• Device Catalogue Number: 502-11-52E
• Device Lot Number: 50716201
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 09/28/2017
• Supplement Date Received by Manufacturer: 12/19/2017; 12/15/2022
• Initial Report FDA Received Date: 10/25/2017
• Supplement Report FDA Received Date: 01/15/2018; 12/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/09/2015
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 45 YR
• Patient Sex: Male
• Patient Weight: 88 KG