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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN CERCLAGE DALL MILES CABLE; HIP IMPLANT
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STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN CERCLAGE DALL MILES CABLE; HIP IMPLANT Back to Search Results
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
This pi is for revision of patient's left hip on (b)(6) 2017.In reporting a revision of patient's left hip on (b)(6) 2018, 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.
 
Manufacturer Narrative
An event regarding loosening and altr (metalosis) involving an unknown dall miles cable was reported.The loosening event was confirmed by medical review however, altr was not confirmed.Method & results: -device evaluation and results: not performed as product was not returned -medical records received and evaluation: a review of the provided medical records and 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.{.} -device history review: could not be performed as lot code information was not provided.-complaint history review: could not be performed as lot code information was not provided.Conclusion: the investigation concluded that loosening was caused by {.} 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.{.} 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 Description
This pi is for revision of patient's left hip on (b)(6)2017.In reporting a revision of patient's left hip on (b)(6)2018, 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.Update (b)(6)2018: medical review received, stated that wear of the dall miles cable is secondary to loosening of the cable.Also stated that due to the use of only one cable "suboptimal fracture stabilization of a previous periprosthetic fracture involving greater and lesser trochanter has contributed to trochanteric non-union with recurrent dislocation as adverse outcome requiring revision.".
 
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Brand Name
UNKNOWN CERCLAGE DALL MILES CABLE
Type of Device
HIP IMPLANT
Manufacturer (Section D)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
MDR Report Key7522922
MDR Text Key108547931
Report Number0002249697-2018-01482
Device Sequence Number1
Product Code JDQ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other
Type of Report Initial,Followup
Report Date 07/18/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/17/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue NumberUNK_SHC
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Date Manufacturer Received06/20/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age87 YR
Patient Weight51
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