MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN 26 MM 10 DEGREE INSERT; HIP IMPLANT

Catalog Number UNK_REC

Device Problems Material Integrity Problem (2978); Naturally Worn (2988)

Patient Problems Pain (1994); Injury (2348)

Event Date 09/15/2016

Event Type  Injury  

Manufacturer Narrative

An event regarding wear involving an unknown liner was reported.The event was confirmed.Device evaluation and results: device was not returned however, explanted device images were provided which shows the insert is worn.Medical records received and evaluation: the provided medical records were deemed insufficient and rejected for medical review.However, the clinician noted that the x-ray confirms worn liner after 25 years, not necessarily loosening.Device history review: not performed as the device was not properly identified.-complaint history review: not performed as the device was not properly identified.The investigation concluded that liner wear was present however, the exact root cause of the event could not be determined because insufficient information was provided.Further information such as operative reports, clinical and past medical history, dated x-rays and examination of explanted components are needed to complete the investigation for determining root cause.If devices and/or additional information become available, this investigation will be reopened.

Event Description

Per sales rep, patient came into dr.Ayres office with pain.She had a complaint of subluxation.Upon x-ray dr.Ayres noticed radiolucency.He also noticed radiolucency in the proximal femur.

Manufacturer Narrative

An event regarding wear involving an unknown liner was reported.The event was confirmed.Method & results: -device evaluation and results: device was not returned however, explanted device images were provided which shows the insert is worn.-medical records received and evaluation: the provided medical records were deemed insufficient and rejected for medical review.However, the clinician noted that the x-ray confirms worn liner after 25 years, not necessarily loosening.-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 liner wear was present however, the exact root cause of the event could not be determined because insufficient information was provided.Further information such as operative reports, clinical and past medical history, dated x-rays and examination of explanted components are needed to complete the investigation for determining root cause.If devices and/or additional information become available, this investigation will be reopened.

Event Description

Per sales rep, patient came into dr.(b)(6) office with pain.She had a complaint of subluxation.Upon x-ray dr.(b)(6) noticed radiolucency.He also noticed radiolucency in the proximal femur.

• Brand Name: UNKNOWN 26 MM 10 DEGREE INSERT
• 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: 6213816
• MDR Text Key: 63560460
• Report Number: 0002249697-2016-04071
• Device Sequence Number: 1
• Product Code: KWZ
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 01/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2016
• 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
• Date Manufacturer Received: 12/02/2016
• 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): Other; Required Intervention
• Patient Age: 72 YR
• Patient Weight: 54