MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT 10° X3 INSERT 28MM ID; HIP JOINT METAL/POLYMER/METAL SEMI-CONSTRAINED POROUS-COATED UNCEMENTED PROSTHES

Catalog Number	623-10-28E
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Codes	Tissue Damage (2104); Injury (2348); Joint Dislocation (2374)
Date of Event	06/13/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the device history records indicates that the reported devices were manufactured and accepted into final stock with no reported discrepancies.The complaint history review indicated that there were no similar events for the reported lot.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Not returned.
Event or Problem Description
Revision of luxated hip revealed massive loss of soft tissue around greater trochanter and accompanying particle debris around the spigot, inside the head trunnion and in the wound as a black pattern.The products revised were accolade tmzf with trident cup.The stem, head and liner were retrieved and available for further inspection.As to marks on the stem, the surgeon used only osteotome around the proximal part of the fixation zone and not on the trunnion.Mark on the head only on the outside to tap out the head.The stem was withdrawn with the threaded accolade2 inserter.No other marks were caused by using osteotome or other instrument.
Additional Manufacturer Narrative
An event regarding impingement leading to range of motion involving a trident liner was reported.The event was confirmed through clinician review of the medical records provided.Method & results: product evaluation and results: visual inspection was performed as part of the material analysis report which indicated: a detailed image of the articulating surface of the insert with burnishing, scratching and third-body indentations being observed.These are common damage modes of uhmwpe.Clinician review: a review of the provided medical records by a clinical consultant indicated: it is however quite clear that the cup rim was subject to device/device impingement because the explant picture shows a typical ¿impingement dimple¿ around the inferior/anterior cup liner rim, consistent with a cup and liner in absent anteversion.Impingement is the first stage of joint instability that proceeds to subluxation and full dislocation with further movement of the hip, also consistent with the clinical history of recurrent dislocation.So, cup malposition contributing to impingement and instability is clear.Cup malposition in absent anteversion and medialized position in combination with gluteal muscular insufficiency after rupture/ fracture of the tip of greater trochanter 2-years earlier have contributed to recurrent dislocation in the arthroplasty requiring revision surgery.The overload condition associated with these two factors contributed to corrosion in the modular femoral head junction with metal debris generation in and around the arthroplasty as secondary adverse effects.Product history review: indicates all devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusion: the material analysis indicated: visual inspection was performed as part of the material analysis report which indicated: a detailed image of the articulating surface of the insert, with burnishing, scratching and third-body indentations being observed.These are common damage modes of uhmwpe.A review of the provided medical records by a clinical consultant indicated: it is however quite clear that the cup rim was subject to device/device impingement because the explant picture shows a typical ¿impingement dimple¿ around the inferior/anterior cup liner rim, consistent with a cup and liner in absent anteversion.Impingement is the first stage of joint instability that proceeds to subluxation and full dislocation with further movement of the hip, also consistent with the clinical history of recurrent dislocation.So, cup malposition contributing to impingement and instability is clear.Cup malposition in absent anteversion and medialized position in combination with gluteal muscular insufficiency after rupture/ fracture of the tip of greater trochanter 2-years earlier have contributed to recurrent dislocation in the arthroplasty requiring revision surgery.The overload condition associated with these two factors contributed to corrosion in the modular femoral head junction with metal debris generation in and around the arthroplasty as secondary adverse effects.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
Revision of luxated hip revealed massive loss of soft tissue around greater trochanter and accompanying particle debris around the spigot, inside the head trunnion and in the wound as a black pattern.The products revised were accolade tmzf with trident cup.The stem, head and liner were retrieved and available for further inspection.As to marks on the stem, the surgeon used only osteotome around the proximal part of the fixation zone and not on the trunnion.Mark on the head only on the outside to tap out the head.The stem was withdrawn with the threaded accolade2 inserter.No other marks were caused by using osteotome or other instrument.

• Brand Name: TRIDENT 10° X3 INSERT 28MM ID
• Common Device Name: HIP JOINT METAL/POLYMER/METAL SEMI-CONSTRAINED POROUS-COATED UNCEMENTED PROSTHES
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 7675322
• Report Number: 0002249697-2018-02113
• Device Sequence Number: 645793
• Product Code: LPH
• UDI-Device Identifier: 07613327039788
• UDI-Public: 07613327039788
• Combination Product (Y/N): N
• Initial Reporter Country: SE
• PMA/510(K) Number: K033716
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/01/2018

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: 11/30/2016
• Device Catalogue Number: 623-10-28E
• Device Lot Number: 38314601
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2018
• Initial Date Received by Manufacturer: 06/13/2018
• Supplement Date Received by Manufacturer: 09/03/2018
• Initial Report FDA Received Date: 07/10/2018
• Supplement Report FDA Received Date: 10/01/2018
• 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; Other; Required Intervention
• Patient Age: 61 YR
• Patient Weight: 83