MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN_RECONSTRUCTIVE_PRODUCT; IMPLANT

Catalog Number UNK_REC

Device Problem Metal Shedding Debris (1804)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 06/16/2014

Event Type  Injury  

Event Description

It was reported patient had a revision of right acetabular.Doctor stated there was significant metallosis between mdm liner and tritanium shell.Also significant metallosis between shell and bone.

Manufacturer Narrative

Catalogue number unknown at this time.Device description reported as an unknown augment an evaluation of the device cannot be performed as the device was not returned to the manufacturer due to hospital policy.Additional information has been requested.Should additional information become available, it will be reported in a supplemental report upon completion of the investigation.Not returned to the manufacturer.

Manufacturer Narrative

The patient is (b)(6) in height.An event regarding metallosis involving a unknown augment was reported.The event was not confirmed.A review of the provided patient details and reported event by a clinical consultant indicated: "issue with a tritanium cup revision with associated mdm liner an unknown time after primary arthroplasty in a female patient of (b)(6) with obesity.Surgeon reported there was significant metallosis between mdm liner and tritanium shell.Also significant metallosis between shell and bone.No x-rays are available for review while also no implants were returned for analysis.The location of the reported metallosis behind mdm shell and between cup shell and bone points to a source of metal debris generation on the back side of the cup while the use of augment and screws most probably points to a failed stabilization of these devices at index surgery when bone grafts were present and a metal augment (titanium or tantalum) was used for additional stabilization.It appears very probable that failure of the cup, augment screw combination failed to acquire stable bony fixation and thus became subject to a loosening process that was accompanied by destabilization of augment and screws and thus was subject to abrasive wear between the involved metal surfaces.This caused pain which established the indication for revision surgery as most probably cup loosening although there is no explicit confirmation fir such due to lack of information.It still appears the most probable failure scenario with the most plausible and compatible explanation of all reported facts and findings.As such, a procedure-related failure mechanism has the highest probability as failure mode although this high suspicion cannot be documented with adequate evidence through x-ray verification of components or explant materials analysis.The probability of device-related mechanisms appears very low to absent while patient obesity may have played a secondary but certainly not a principal role in the failure scenario." conclusions: the exact cause of the event could not be determined because no medical records and/or device were received.Clinical consultant indicated it appears very probable that failure of the cup, augment screw combination failed to acquire stable bony fixation and thus became subject to a loosening process that was accompanied by destabilization of augment and screws and thus was subject to abrasive wear between the involved metal surfaces.Further information such as pre- and post-operative x-rays and the primary operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.

Event Description

It was reported patient had a revision of right acetabular.Doctor stated there was significant metallosis between mdm liner and tritanium shell.Also significant metallosis between shell and bone.

• Brand Name: UNKNOWN_RECONSTRUCTIVE_PRODUCT
• Type of Device: 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: 3926473
• MDR Text Key: 4496406
• Report Number: 0002249697-2014-02621
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2014
• 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: 09/18/2014
• 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
• Patient Age: 50 YR
• Patient Weight: 86