MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT 10° CROSSFIRE INSERT 26 MM ID; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	621-10-26D
Medical Device Problem Codes	Use of Device Problem (1670); Loss of Osseointegration (2408)
Health Effect - Clinical Code	Pain (1994)
Date of Event	03/13/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Right tha was performed on (b)(6) 2007.The patient started going to the hospital several years ago due to pain of the surgery site.The doctor postponed the revision surgery because no osteolysis was detected while he found loosening of the cup.However, the patient complained of increased pain after she fell down, so on (b)(6) 2024, the revision surgery was performed to replace the devices (the cup, the insert, and the head) except the stem.When the doctor checked the removed devices, it was found that inner diameter of the removed head was 22mm, which was different from inner diameter of the removed insert, 26mm.The doctor requests the stryker to investigate wear location and wear depth of the insert because he suspects that the wear of the insert is one of the root cause of the cup loosening.
Additional Manufacturer Narrative
An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.
Additional Manufacturer Narrative
Reported event: an event regarding incorrect selection and wear involving a trident liner was reported.The incorrect selection of implants resulting in the mismatch of size between the head and the liner was confirmed.Method & results: -product evaluation and results: visual inspection: visual inspection of the returned device indicated that the device has minor surface damage in the form of scratches and discoloration.Damage is consistent with explantation and time spent implanted.The yellow discoloration observed on the liner is consistent with the absorption of synovial fluid by the device.No obvious wear is observed.-clinician review: a review of the provided medical records by a clinical consultant indicated: "i can confirm that the patient had both a primary and revision procedure because i was able to examine pre-revision and post revision x-rays.Root cause analysis: the root cause of this event cannot be determined with certainty.In fact, after reviewing this case it appears that the event is not loosening of the acetabular component but rather malposition of the component, mismatch of the femoral head and polyethylene liner, and rather severe polyethylene wear.The causes of this event are multifactorial including surgical technique, especially in the fact that the acetabular component in my view does not appear to be loose but rather to be malposition.I would be happy to examine serial x-rays to see if there was any change in the position of the cup that would indicate loosening.There is no doubt that there was surgeon error in allowing a mismatch of the femoral head and the polyethylene liner.I believe it is a tribute to the crossfire polyethylene that it survived over 17 years without failure despite the mismatch.Of course whenever there is polyethylene wear one can also implicate patient lifestyle, bmi, and activity level as well as implant factors.However with the information provided.I would not necessarily assign causality to the implant itself due to the mismatch and malposition." -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's hip was revised due to pain.Intra-operatively it was found that inner diameter of the removed head was 22mm, which was different from inner diameter of the removed insert, 26mm.A review of the provided medical records by a clinical consultant indicated: "i can confirm that the patient had both a primary and revision procedure because i was able to examine pre-revision and post revision x-rays.Root cause analysis: the root cause of this event cannot be determined with certainty.In fact, after reviewing this case it appears that the event is not loosening of the acetabular component but rather malposition of the component, mismatch of the femoral head and polyethylene liner, and rather severe polyethylene wear.The causes of this event are multifactorial including surgical technique, especially in the fact that the acetabular component in my view does not appear to be loose but rather to be malposition.I would be happy to examine serial x-rays to see if there was any change in the position of the cup that would indicate loosening.There is no doubt that there was surgeon error in allowing a mismatch of the femoral head and the polyethylene liner.I believe it is a tribute to the crossfire polyethylene that it survived over 17 years without failure despite the mismatch.Of course whenever there is polyethylene wear one can also implicate patient lifestyle, bmi, and activity level as well as implant factors.However, with the information provided.I would not necessarily assign causality to the implant itself due to the mismatch and malposition." no further investigation for this event is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
Right tha was performed on (b)(6) 2007.The patient started going to the hospital several years ago due to pain of the surgery site.The doctor postponed the revision surgery because no osteolysis was detected while he found loosening of the cup.However, the patient complained of increased pain after she fell down, so on (b)(6) 2024, the revision surgery was performed to replace the devices (the cup, the insert, and the head) except the stem.When the doctor checked the removed devices, it was found that inner diameter of the removed head was 22mm, which was different from inner diameter of the removed insert, 26mm.The doctor requests the stryker to investigate wear location and wear depth of the insert because he suspects that the wear of the insert is one of the root cause of the cup loosening.

• Brand Name: TRIDENT 10° CROSSFIRE INSERT 26 MM ID
• 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 NA ; EI NA
• Manufacturer Contact: marisol santiago ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 19070373
• Report Number: 0002249697-2024-00569
• Device Sequence Number: 17343142
• Product Code: LPH
• UDI-Device Identifier: 07613327037678
• UDI-Public: 07613327037678
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K983382
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/05/2024

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: 10/31/2011
• Device Catalogue Number: 621-10-26D
• Device Lot Number: 20510401
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/13/2024
• Supplement Date Received by Manufacturer: 07/10/2024
• Initial Report FDA Received Date: 04/09/2024
• Supplement Report FDA Received Date: 08/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/11/2006
• 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: 79 YR
• Patient Sex: Female