MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH PRIMARY TRITANIUM HEMI SOLIDBACK CUP 52MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	500-03-52D
Medical Device Problem Codes	Unstable (1667); Osseointegration Problem (3003)
Health Effect - Clinical Codes	Pain (1994); Inadequate Osseointegration (2646)
Date of Event	10/14/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient had a primary right hip replacement in 2015 and patient reported experiencing instability and pain.Patient reported a "trident 1 titanium cup first generation failed to have bone ingrowth".
Additional Manufacturer Narrative
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.
Additional Manufacturer Narrative
Reported event: an event regarding loosening involving a trident shell was reported.The event was confirmed via clinician review.Method & results: -device evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device remains implanted.-clinician review: a review of medical records by a clinical consultant indicated: "this is a case of failure of a highly porous coated acetabular component to achieve satisfactory fixation after implantation.It is not the case that the implant had a satisfactory radiographic appearance and then developed radiolucency and signs of lack of bone in growth.Rather i believe this implant was most likely not well fixed at surgery.I can confirm that the right total hip arthroplasty took place on (b)(6), 2015 since i was able to review the operation report and postoperative x-rays.I am able to confirm that the acetabular component exhibited signs of lack of intimate bone/implant contact as early as (b)(6) 2015 since it is visible on an x-ray on that date.I cannot determine the root cause of failure to achieve stable bony fixation with certainty.The causes are multifactorial.Having said that, this is not a typical case of loosening where fixation was achieved and then lost.As early as one month after surgery the patient exhibited signs of lack of intimate contact between the host bone and the implant.The cause of the radiographic finding of a complete radiolucency with dentate line, four weeks after a primary procedure is virtually always surgical technique related.While i do have the x-ray at four weeks after surgery, i do not have the immediate postop x-ray to see what contact if any was achieved.If intimate contact was achieved, one could also implicate patient factors such as bmi, activity level and possibly trauma as a cause of loss of fixation.In this case i would postulate that reaming was carried out possibly excessively or eccentrically or that the cavity created was too large for the implant chosen.I have had extensive personal experience with this implant and reaming line to line or 1 mm under (depending on the characteristics of the host bone) has always achieved initial satisfactory stability with satisfactory postoperative appearance on x-ray.If satisfactory initial fixation was in doubt, one or more screws could have been used as adjunct fixation." -device 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 reported lot.Conclusion: 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.
Event or Problem Description
Patient had a primary right hip replacement in 2015 and patient reported experiencing instability and pain.Patient reported a "trident 1 titanium cup first generation failed to have bone ingrowth".Update 09/november/2022 wg: as reported via mw5113066: implanted: stryker tritanium hemispherical solid back shell, trident x3 insert, and accolade ii 127 degree angle hip stem and biolox delta femoral head.The cup never developed bony ingrowth and has not attached after 5 years.Was told that the first generation material is known for this problem which is why i am reporting this maude database.Have medical records.Please note i am filing this against the back shell component.I was told it was the "cup" that failed to develop ingrowth due to material.The hip has never felt "right" and it has never been without pain.Hip device failed to develop bony ingrowth and attach.

• Brand Name: PRIMARY TRITANIUM HEMI SOLIDBACK CUP 52MM
• 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-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: diana rogers ; 210 centennial avenue; centennial park, elstree; borehamwood WD6 3-SJ ; UK WD6 3SJ ; 2082386500
• MDR Report Key: 15749740
• Report Number: 0002249697-2022-01597
• Device Sequence Number: 17721464
• Product Code: LPH
• UDI-Device Identifier: 07613327040043
• UDI-Public: 07613327040043
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K081171
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/30/2023

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: 01/31/2020
• Device Model Number: 500-03-52D
• Device Catalogue Number: 500-03-52D
• Device Lot Number: YX7371
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/14/2022
• Supplement Date Received by Manufacturer: 01/07/2023
• Initial Report FDA Received Date: 11/07/2022
• Supplement Report FDA Received Date: 01/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/23/2015
• 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: Required Intervention; Hospitalization
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Weight: 80 KG