MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT PSL HA SOLID BACK 50MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	540-11-50E
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Injury (2348); Joint Dislocation (2374)
Date of Event	05/08/2020
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.
Event or Problem Description
This pi is for the revision of the patient's hip on (b)(6) 2020.As reported: "the patient had her primary hip done in 2012 in new york.A cement stem was placed and a 50 trident psl cup.Patient had recurrent dislocations and received revision surgery on (b)(6) 2020.At that time it was found that the cup was solid and didn¿t need removal so we placed an mdm liner for the e cup with a 28 +8 metal head.Final xrays looked good but noted the original cup position was vertical.We recently found out that the patient was again dislocated [while tying shoe.Hip popped out].This time, she dissociated the small head from the large mdm head.Please note that i was in the previous surgery and know that the head construct was properly put together.We removed the head and liner head and removed the psl cup.She then placed a 52 multihole trident ii cup and constrained liner.".
Event or Problem Description
This pi is for the revision of the patient's hip on (b)(6) 2020.As reported: "the patient had her primary hip done in 2012 in new york.A cement stem was placed and a 50 trident psl cup.Patient had recurrent dislocations and received revision surgery on (b)(6) 2020.At that time it was found that the cup was solid and didn¿t need removal so we placed an mdm liner for the e cup with a 28 +8 metal head.Final xrays looked good but noted the original cup position was vertical.We recently found out that the patient was again dislocated [while tying shoe.Hip popped out].This time, she dissociated the small head from the large mdm head.Please note that i was in the previous surgery and know that the head construct was properly put together.We removed the head and liner head and removed the psl cup.She then placed a 52 multihole trident ii cup and constrained liner.".
Additional Manufacturer Narrative
Reported event: an event regarding malposition involving a trident shell was reported.The event was not confirmed.Method & results -product evaluation and results: the metal head was returned for evaluation.Explanation damage was noticed on the device.-medical records received and evaluation: a review of the provided medical records by a clinical consultant indicated: ap right hip - hybrid right tha reduced, no screws in acetabulum, acet.Shell vertical, large head.Ap pelvis and ap right hip same acet and stem, smaller collared head in mdm liner.2 ap pelvis same stem, new acetabulum with screws, nominal position and reduced into constrained liner.No clinical or pmh, no operative reports, no examination of explanted components, no dated serial x-rays demonstrating dislocations.Based upon the information available for review, no confirmation of the event descriptions or creation of a medical report is possible.-product history review: a review of the device manufacturing records indicate that all devices accepted into final stock were free from discrepancies.-complaint history review: there have been no other similar events for the lot referenced.Conclusions: a review of the provided medical records by a clinical consultant indicated: no clinical or pmh, no operative reports, no examination of explanted components, no dated serial x-rays demonstrating dislocations.Based upon the information available for review, no confirmation of the event descriptions or creation of a medical report is possible.No further investigation for this event is possible at this time as insufficient information was received by stryker orthopaedics.If additional information become available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: TRIDENT PSL HA SOLID BACK 50MM
• 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: 10108800
• Report Number: 0002249697-2020-01010
• Device Sequence Number: 3342510
• Product Code: LPH
• UDI-Device Identifier: 04546540237828
• UDI-Public: 04546540237828
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K143085
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/14/2020

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: 07/31/2023
• Device Model Number: 540-11-50E
• Device Catalogue Number: 540-11-50E
• Device Lot Number: 40931401
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2020
• Initial Date Received by Manufacturer: 05/08/2020
• Supplement Date Received by Manufacturer: 08/18/2020
• Initial Report FDA Received Date: 06/02/2020
• Supplement Report FDA Received Date: 09/14/2020
• 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: Hospitalization; Required Intervention
• Patient Age: 68 YR
• Patient Weight: 74