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

Catalog Number UNK_REC

Device Problems Material Integrity Problem (2978); Insufficient Information (3190)

Patient Problems Injury (2348); Osteolysis (2377)

Event Date 10/31/2015

Event Type  Injury  

Manufacturer Narrative

Should additional information become available, it will be reported in a supplemental report upon completion of the investigation.Not returned to manufacturer.

Event Description

This is from conference presentation in (b)(6).It was reported that after tha surgery using omnifit, revision surgery due to a wear of the liner and osteolysis around the cup was performed.

Manufacturer Narrative

An event regarding wear involving an unknown liner was reported.The event was not confirmed.Method and results: device evaluation and results: a visual, dimensional and functional inspection was not performed as the device was not returned for evaluation.Medical records received and evaluation: a review of the provided information by a clinical consultant concluded that :18-years of service life in a first generation polyethylene liner results in wear rates that are consistent with end of practical service life of the device, consistent with the limited facts and findings reported.Device history review could not be performed as the device lot is unknown.Complaint history review could not be performed as the device lot is unknown.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Further information such as return of device, operative reports, xrays, patient history & follow-up notes are needed to investigate this event further.If additional information and/or device become available, this investigation will be reopened.

Event Description

This is from conference presentation in ¿(b)(6) 2015." it was reported that after tha surgery using omnifit, revision surgery due to a wear of the liner and osteolysis around the cup was performed.

• 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: beverly lima ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5248588
• MDR Text Key: 32093247
• Report Number: 0002249697-2015-04062
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• 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: 11/10/2015

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?: Yes
• 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: 11/10/2015
• Initial Date FDA Received: 11/24/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/19/2016
• 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): Required Intervention