MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH RESTORATION ADM X3 INS 28/48; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU

Catalog Number 1236-2-848

Device Problems Scratched Material (3020); Insufficient Information (3190)

Patient Problems Loss of Range of Motion (2032); No Consequences Or Impact To Patient (2199)

Event Date 12/30/2015

Event Type  malfunction  

Manufacturer Narrative

A supplemental report will be submitted upon completion of the investigation.

Event Description

It was reported that surgeon was doing a left total hip and upon implantation of devices, surgeon tested for range of motion and noticed the devices were not articulating as they should so surgeon removed components and implanted new components.Surgeon noted that upon removal of devices surgeon noticed that devices had scratches on the surfaces.On (b)(6) 2016, the sales rep indicated that the surgeon trialed to the correct size and implanted the final mobile bearing implants.Upon completing a range of motion check, the surgeon noticed that the outer bearing would not articulate with the metal mdm liner.The surgeon removed the adm poly liner and head and noticed that the liner was severely scratched.He carefully implanted a new adm poly liner and head and experienced the same articulation issue.Additionally, upon dislocation of the hip to remove the components, he noticed that the surface of the second poly liner was severely scratched again.Therefore, the surgeon removed the mdm liner, poly and head and re-implanted with 40 mm fixed bearing and completed the case successfully.

Manufacturer Narrative

An event regarding a rom (range of motion) issue involving an adm liner was reported.The event was not confirmed.Visual inspection: the adm liner was returned with the metal head inserted.Extensive scratches were observed on the articulating surface of the returned adm liner.These scratches are consistent with explanation damage.Dimensional inspection: a dimensional inspection could not be performed due to the extent of the damage to the articulating surface of the returned adm liner.However a review of the device history record confirmed that all devices are were dimensionally within specification as per igs-0029573 at the time of release.Functional inspection: a functional inspection was not performed as the event cannot be replicated.Medical records received and evaluation: a review by a clinical consultant noted: there are x-rays but only prior to arthroplasty that indicate severe degenerative changes in the hip consistent with the indication for surgery.There is a surgical report that documents the problems as outlined in the pi intake as well as above but provides no further clues to the cause of the problem.Based upon available information it is not possible to establish a root cause of failure for this event device history review: all devices in the reported lot were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there have been no other similar events for the reported lot.Conclusions: a review by a clinical consultant concluded: based upon available information it is not possible to establish a root cause of failure for this event.If additional information become available, this investigation will be reopened.

Event Description

It was reported that surgeon was doing a left total hip and upon implantation of devices, surgeon tested for range of motion and noticed the devices were not articulating as they should so surgeon removed components and implanted new components.Surgeon noted that upon removal of devices surgeon noticed that devices had scratches on the surfaces.On (b)(6) 2016, the sales rep indicated that the surgeon trialed to the correct size and implanted the final mobile bearing implants.Upon completing a range of motion check, the surgeon noticed that the outer bearing would not articulate with the metal mdm liner.The surgeon removed the adm poly liner and head and noticed that the liner was severely scratched.He carefully implanted a new adm poly liner and head and experienced the same articulation issue.Additionally, upon dislocation of the hip to remove the components, he noticed that the surface of the second poly liner was severely scratched again.Therefore, the surgeon removed the mdm liner, poly and head and re-implanted with 40 mm fixed bearing and completed the case successfully.

• Brand Name: RESTORATION ADM X3 INS 28/48
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NA
• Manufacturer Contact: keyla colon ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5391751
• MDR Text Key: 37042485
• Report Number: 0002249697-2016-00190
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093644
• 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: 12/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2020
• Device Catalogue Number: 1236-2-848
• Device Lot Number: 53004501
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/05/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/07/2015
• 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
• Patient Age: 73 YR