MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN INSERT; HIP IMPLANT

Catalog Number UNK_SHC

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Injury (2348); Joint Dislocation (2374)

Event Date 09/18/2017

Event Type  Injury  

Manufacturer Narrative

It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.

Event Description

Record is for revision of patient's left hip on (b)(6) 2017.In reporting a revision of a patient's left hip on (b)(6) 2018, the rep supplied an operative report which identified a revision took place on 09/18/17.As reported in the operative report: "preoperative diagnoses: recurrent dislocation of left revision total hip arthroplasty.Nonunion of left greater trochanter.A fair amount of metal staining was present from a loose [dall-miles] cerclage cable.This was retrieved".As per medical document, the mdm liner was removed to implant a constrained liner.The cone body was removed to implant a cone body with holes for passage of dall-miles cables.

Manufacturer Narrative

An event regarding dislocation and altr (metalosis) involving a unknown liner was reported.The dislocation event was confirmed by medical review however, altr was not confirmed.Method & results: -product evaluation and results: not performed as the device was not returned.-medical records received and evaluation: a review of the provided medical records and/or x-rays by a clinical consultant indicated: conclusion of assessment suboptimal fracture stabilisation of a previous periprosthetic fracture involving greater and lesser trochanter has contributed to trochanteric non-union with recurrent dislocation as adverse outcome requiring revision.Does the review identify any procedural related factors that contributed to the event? - quality of stabilisation of the fracture is related to surgical technique and adequate devices and techniques do exist to adequately treat this problem.Single dm-cable can never stabilise a full fracture.Does the review identify any patient related factors that contributed to the event? - periprosthetic fracture after a fall is the initiating event to have required implantation of the predicate devices.Does the review identify any device related factors that caused or contributed to the adverse event? - no device-related factors are associated with any of the implanted devices.The reported metallosis is secondary to loosening of the dm-cable after failure of fracture healing.-product history review: not performed as the device lot details were not provided.-complaint history review: not performed as the device lot details were not provided.Conclusions: the medical review concluded the following: suboptimal fracture stabilisation of a previous periprosthetic fracture involving greater and lesser trochanter has contributed to trochanteric non-union with recurrent dislocation as adverse outcome requiring revision.Altr could not be confirmed nor could its root cause be determined because insufficient information was provided.Further information such as histopathology reports, pre- and post-operative x-rays and the primary operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.No further investigation for this event is required at this time.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.

Event Description

Record is for revision of patient's left hip on (b)(6)2017 in reporting a revision of a patient's left hip on (b)(6)2018, the rep supplied an operative report which identified a revision took place on (b)(6)2017.As reported in the operative report: "preoperative diagnoses: recurrent dislocation of left revision total hip arthroplasty.Nonunion of left greater trochanter.A fair amount of metal staining was present from a loose [dall-miles] cerclage cable.This was retrieved".As per medical document, the mdm liner was removed to implant a constrained liner.The cone body was removed to implant a cone body with holes for passage of dall-miles cables.

• Brand Name: UNKNOWN INSERT
• Type of Device: HIP IMPLANT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 7523372
• MDR Text Key: 108566013
• Report Number: 0002249697-2018-01484
• Device Sequence Number: 1
• Product Code: JDQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 07/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_SHC
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 87 YR
• Patient Weight: 51