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

Catalog Number UNK_REC

Device Problems Mechanical Problem (1384); Device Dislodged or Dislocated (2923); Unintended Movement (3026)

Patient Problems Tissue Damage (2104); Injury (2348); Joint Dislocation (2374); Reaction (2414)

Event Date 10/11/2016

Event Type  Injury  

Manufacturer Narrative

Reported event: an event regarding instability involving an unknown liner was reported.The event was confirmed.Method and results: device evaluation and results: a visual, functional and dimensional inspection could not be performed as the device was not returned; medical records received and evaluation: the provided medical records were reviewed by consulting clinician who indicated: "the primary harm involved is recurrent instability of the hip.The poor condition of the hip abductors undoubtedly plays a role in the recurrent instability.No evidence of implant design or manufacturing is presented.The patient had mildly elevate blood co,cr and ti ion levels and staining of the tissues with metallosis.The nature of the staining is not known.While it might be related to corrosion and wear of the trunion and head it also may reflect abnormal wear of the edge of the titanium cup as it articulated abnormally with a dislocated femoral head.There is insufficient documentation presented to complete this assessment."; device history review: not performed as the device was not properly identified; complaint history review: not performed as the device was not properly identified.Conclusions: the investigation concluded that instability was confirmed by the consulting clinician.The primary harm involved is recurrent instability of the hip.The poor condition of the hip abductors undoubtedly plays a role in the recurrent instability.No evidence of implant design or manufacturing is presented.If additional information and/or device becomes available, this investigation will be reopened.Product surveillance will continue to monitor for trends.

Event Description

The customer reported that the female patient presented with dislocation.She was revised on (b)(6) 2016 and the surgeon reported metallosis.Images of explanted devices indicate black on stem trunnion and inside the head.The surgeon further reported that the muscle of the abductors destroyed by armd.Patient had dislocation of thr 3 times prior to revision.Right side.

Manufacturer Narrative

An event regarding dislocation involving an unknown liner was reported.The event was confirmed.Method & results: -device evaluation and results: a visual, functional and dimensional inspection could not be performed as the device was not returned.-medical records received and evaluation: the provided medical records were reviewed by consulting clinician who indicated: "the primary harm involved is recurrent instability of the hip.The poor condition of the hip abductors undoubtedly plays a role in the recurrent instability.No evidence of implant design or manufacturing is presented.The patient had mildly elevate blood co, cr and ti ion levels and staining of the tissues with metallosis.The nature of the staining i.E., is not known.While it might be related to corrosion and wear of the trunnion and head it also may reflect abnormal wear of the edge of the titanium cup as it articulated abnormally with a dislocated femoral head.There is insufficient documentation presented to complete this assessment." -device history review: not performed as the device was not properly identified.-complaint history review: not performed as the device was not properly identified.Conclusions: the investigation concluded that reported event of dislocation.The clinician determined that the root cause of the event could have been the poor condition of the hip abductors however, there is insufficient documentation presented to complete this assessment.No evidence of implant design or manufacturing is presented.Further information such as primary operative report, implant records, dated pre- and post-op x-ray images, clinical notes and the explanted devices are needed to complete the investigation for determining root cause.If additional information and/or device becomes available, this investigation will be reopened.

Event Description

The customer reported that the female patient presented with dislocation.She was revised on (b)(6) 2016 and the surgeon reported metallosis.Images of explanted devices indicate black on stem trunnion and inside the head.The surgeon further reported that the muscle of the abductors destroyed by armd.Patient had dislocation of thr 3 times prior to revision.Right side.

• Brand Name: UNKNOWN LINER
• Type of Device: HIP IMPLANT
• 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: cindy chuhinko ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6171422
• MDR Text Key: 62311280
• Report Number: 0002249697-2016-03896
• Device Sequence Number: 1
• Product Code: JDG
• Combination Product (y/n): N
• Reporter Country Code: GB
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/26/2017

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
• Device Operator: Health Professional
• Device Catalogue Number: UNK_REC
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/15/2016
• Initial Date FDA Received: 12/13/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/26/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 78 YR