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

Model Number	623-00-36D
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Pain (1994)
Date of Event	12/19/2014
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The following devices were also listed in this report: primary tritanium hemi solidback cup 52mm; cat#: 500-03-52d; lot#: mnpdnn size 6 accolade ii 132 deg; cat#: 6720-0635; lot#: 47739904; delta v-40 ceramic head 36/0; cat#: 6570-0-136; lot#: 48924001.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.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.Device not returned.
Event or Problem Description
Patient called stating he had a left hip replacement done and would like to know if his implants were involved in a recall.Patient is asymptomatic.Update 20-dec-2019: spoke to patient and he stated he is experiencing pain and feels like his hip gives out as he walks.
Additional Manufacturer Narrative
An event regarding pain involving a trident 0 deg insert 36mm was reported.The event was not confirmed.Method & results: -device evaluation and results: not performed as product was not returned -clinician review: clinical review: a review of the provided medical records and/or x-rays by a clinical consultant rejected and stated that : patient stated she was asymptomatic when she first called.When recall results were provided, the patient mentioned she is experiencing some symptoms (unknown).Will follow up with patient regarding her symptoms.Opt report provided does not state any issues.-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.Conclusions: a review of the provided medical records and/or x-rays by a clinical consultant rejected and stated that : patient stated she was asymptomatic when she first called.When recall results were provided, the patient mentioned she is experiencing some symptoms (unknown).Will follow up with patient regarding her symptoms.Opt report provided does not state any issues thus the event could not be confirmed nor the root cause determined due to the minimal information received.No further investigation for this event is possible at this time as no devices and insufficient information was received by stryker orthopedics.If devices and / or additional information become available, this investigation will be reopened.Product surveillance will continue to monitor for trends.It was reported that the customer was inquiring if the reported device is subject to a recall.However, none of these product catalog/lot #¿s were involved in a recall.
Event or Problem Description
Patient called stating he had a left hip replacement done and would like to know if his implants were involved in a recall.Patient is asymptomatic.Update 20-dec-2019: spoke to patient and he stated he is experiencing pain and feels like his hip gives out as he walks.

• Brand Name: TRIDENT 0 DEG INSERT 36MM
• 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: 9603200
• Report Number: 0002249697-2020-00129
• Device Sequence Number: 2490345
• Product Code: LPH
• UDI-Device Identifier: 07613327025309
• UDI-Public: 07613327025309
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K062419
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/28/2020

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: 11/30/2019
• Device Model Number: 623-00-36D
• Device Catalogue Number: 623-00-36D
• Device Lot Number: MNRL9T
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/20/2019
• Supplement Date Received by Manufacturer: 12/31/2019
• Initial Report FDA Received Date: 01/17/2020
• Supplement Report FDA Received Date: 01/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 38 YR
• Patient Weight: 88