MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH MD VIT SLV AND 2.0MM HOMOG CBL; BONE FIXATION CERCLAGE

Catalog Number 6704-0-510

Device Problem Fracture (1260)

Patient Problems Edema (1820); Inflammation (1932); Pain (1994); Injury (2348); Reaction (2414)

Event Date 08/01/2008

Event Type  Injury  

Manufacturer Narrative

An event regarding altr involving a dalls miles cable was reported.The event was confirmed by medical review.Method & results: product evaluation and results: a material analysis has been performed.The report concluded: the cables fractured in overload.Eds showed the cable and cable grip were consistent with astm f90 alloy.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.Clinician review: a review of the provided medical records by a clinical consultant revealed: ¿on (b)(6) 2018 the patient underwent revision surgery.Intra-operatively a large pseudotumor was identified in the posterior aspect of the hip along with a great deal of metallosis.The femoral and acetabular implants were reported to be well fixed and were maintained.The femoral head and liner were exchanged to provide new bearing surfaces and the cables and trochanteric grip were removed as well.¿ [¿] ¿images from an mri of the right hip were also reviewed.These images demonstrate the presence of a mass in the posterolateral aspect of the hip involving the external rotators.These findings were corroborated by the surgeon in his operative report, ¿we opened up the fascia and the it band and exposed the external rotator sleeve.There was a large pseudotumor here.It was maybe 12-14 cm in long dimension and had a large thick rind with appearance of metallosis and darkening of the tissues¿.¿¿ [¿] ¿review of these records confirm revision surgery for pain and increased serum metal ion levels in a hip resurfacing occurred.Both mri and intra-operative findings demonstrate the presence of a pseudotumor involving the external rotators of the hip.During the first surgery an iatrogenic fracture of the calcar occurred requiring cabling.In the operative report of the revision surgery there was no mention of any fraying or disruption of the cables and grip making there possible contribution to the metallosis seen unlikely." product history review: a device history review confirmed all devices accepted into finished goods conformed to specification.Complaint history review: no other events were reported for the lot indicated.Conclusions: the investigation confirmed the event of altr however, the root cause could not be confirmed.Although the mar stated that the cables fractured in overload, the medical review noted that in the x-ray images and during the revision the cables were removed and no fracture was noted.Therefore, the fracture may have occurred post-operatively or during explantation.Further information is needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

Event Description

Patient called stating she had a right hip replacement in (b)(6) 2008, she stated she had experienced pain for several years and pt hasn't helped much.Patient is scheduled for a revision surgery in 2 weeks due to loosening of stem and elevated levels of cobalt and chromium.Patient also wants to know if her implant was subject to a recall.Update 30-nov-2018: patient was revised (b)(6) 2018.Update 11/december/2018: rep reported that the patient's right hip was revised after patient complaint of pain, and due to metal on metal bearing surface.Intraoperatively, a large pseudo-tumor was noted.Additional update 11/december/2018: revision operative report supplied by rep indicated the 46mm unipolar head, sleeve, and 3 cables were explanted and "mdm with a 46mm outer diameter and 28mm +8 metallic head" were implanted.Update 22/april/2019: medwatch (mw5085656) received, patient reported " [.] i was in excruciating pain for years and suffered numerous health problems including an unexplained heart attack on [.] 2017".

• Brand Name: MD VIT SLV AND 2.0MM HOMOG CBL
• Type of Device: BONE FIXATION CERCLAGE
• 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: sharon rivas ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 8615314
• MDR Text Key: 145225957
• Report Number: 0002249697-2019-01954
• Device Sequence Number: 1
• Product Code: JDQ
• UDI-Device Identifier: 07613327036442
• UDI-Public: 07613327036442
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K945294
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2012
• Device Catalogue Number: 6704-0-510
• Device Lot Number: 21276401
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2018
• Date Manufacturer Received: 04/18/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/16/2007
• 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): Hospitalization; Required Intervention
• Patient Age: 70 YR
• Patient Weight: 54