MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ABGII NO4 CEMENTLESS LEFT V40; HIP JOINT FEMORAL (HEMI-HIP) METAL/POLYMER CEMENTED OR UNCEMENTED PROSTHESIS.

Catalog Number 4845-0204

Device Problems Degraded (1153); Material Integrity Problem (2978); Noise, Audible (3273)

Patient Problems Injury (2348); No Information (3190)

Event Date 11/10/2015

Event Type  Injury  

Manufacturer Narrative

Additional information has been requested and if received, will be provided in the supplemental report upon completion of the investigation.Device remains implanted.

Event Description

The surgeon reported that he carried out revision surgery to the left hip of a female patient which had been implanted previously with an abg stem, alumina head, alumina liner and trident cup.The surgeon further reported that a decision to revise the patient was based on an audible squeaking noise when the patient walked which was causing the patient social embarrassment in the workplace.The surgeon reported that only the head and the liner were revised and that the stem remained implanted.The surgeon further reported slight wear on the middle portion of the trunnion which looked like there had been impingement, which he wouldn't have expected with a normal gait.The surgeon further reported that he could see black in and around the implant.

Manufacturer Narrative

An event regarding wear involving an abgii stem was reported.The event was confirmed for wear and metallosis (altr) from the medical review.Method and results: device evaluation and results: not performed as the device was not returned.Medical records received and evaluation: a review of the medical records by a clinical consultant noted: revision of ceramic liner and femoral head in trident cup with abg-ii stem due to severe squeaking some 2-years post implantation in a female patient of (b)(6) with near normal body weight.X-rays document an adequate cup inclination but a low anteversion with protruding superior cup rim into the joint space.During revision surgery impingement was noted between abg stem neck and acetabular sleeve rim with ¿kissing lesions.¿ some metallosis of the capsule was observed as well.The mar reports that metal transfer markings and a wear scar were visible on the articulating surface of the ceramic head.Evidence of impingement was observed on the insert.No material or manufacturing defects were observed on the surfaces examined.The surface roughness, diameter and sphericity measurement results on the femoral head and insert were consistent with in-vivo service.Diagnosis: cup position in low anteversion contributed to impingement causing an overload condition in the bearing with point contact between ceramic surfaces with a wear scar as result.Wear scars contribute to increased bearing friction which generates a squeaking sound requiring revision with bearing exchange to a low-friction poly/metal articulation.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 has been no other similar event for the lot reported.Conclusion: a review of the medical records by a clinical consultant concluded: cup position in low anteversion contributed to impingement causing an overload condition in the bearing with point contact between ceramic surfaces with a wear scar as result.Wear scars contribute to increased bearing friction which generates a squeaking sound requiring revision with bearing exchange to a low-friction poly/metal articulation.No further investigation for this event is possible at this time.If devices and/or additional information become available, this investigation will be reopened.

Event Description

The surgeon reported that he carried out revision surgery to the left hip of a female patient which had been implanted previously with an abg stem, alumina head, alumina liner and trident cup.The surgeon further reported that a decision to revise the patient was based on an audible squeaking noise when the patient walked which was causing the patient social embarrassment in the workplace.The surgeon reported that only the head and the liner were revised and that the stem remained implanted.The surgeon further reported slight wear on the middle portion of the trunnion which looked like there had been impingement, which he wouldn't have expected with a normal gait.The surgeon further reported that he could see black in and around the implant.

• Brand Name: ABGII NO4 CEMENTLESS LEFT V40
• Type of Device: HIP JOINT FEMORAL (HEMI-HIP) METAL/POLYMER CEMENTED OR UNCEMENTED PROSTHESIS.
• 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: beverly lima ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5263428
• MDR Text Key: 32590491
• Report Number: 0002249697-2015-04120
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: GB
• PMA/PMN Number: K121308
• 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?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2018
• Device Catalogue Number: 4845-0204
• Device Lot Number: G3310164C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/10/2015
• Initial Date FDA Received: 12/03/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/04/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/12/2013
• 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: 68 YR
• Patient Weight: 70