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

Catalog Number UNK_SHC

Device Problem Insufficient Information (3190)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 05/01/2013

Event Type  Injury  

Event Description

The customer has reported via the mhra, that a male patient, dob (b)(6), has allegedly suffered pseudotumour after undergoing surgery on his left hip in (b)(6) 2013.The customer has reported the following after carrying out an mri on the patient: "there is a sizeable trochanteric fluid collection at the left hip with thickened and irregular walls which extends into the capsule.The gluteal tendons are grossly intact though the anterolateral head of gluteus medius is a little ragged and there is mild atrophy of the gluteal musculature more proximally.The appearances would be suspicious for armd.".

Manufacturer Narrative

The catalog number and lot code were not provided.The device was reported as an unknown exeter stem.It was noted that the devices were not explanted and the date of the revision surgery is unknown.Additional information has been requested and if received, will be provided in the supplemental report upon completion of the investigation.Not explanted.

Manufacturer Narrative

An event regarding allergic/reaction involving an unknown exeter stem was reported.The event was confirmed.Medical records received and evaluation: a medical review was performed based on the medical information received.The review concluded: "issue with surgeon concern for presence of allegedly pseudotumor after undergoing hip replacement surgery on his left hip in (b)(6) 2013.An mri section shows fluid accumulation in the left hip greater trochanteric area with also some damage in the gluteal musculature nearby.The appearances would be suspicious for armd (adverse reaction to metal devices).Metal ions are reportedly elevated although no exact values were provided for either cobalt or chrome.The exeter stem has stable cemented position although there is some demarcation between cement and bone in the upper stem section and slight migration within the cement mantle.There is osteolysis around the lateral greater trochanteric area with some bone disappearance far lateral proximal in same area.The uninvolved right hip has a restoration modular (rm) system implanted after a revision procedure with a large bone defect in the lateral femoral bone and pseudarthrosis in the greater trochanter.There are three dall-miles (dm) cables one of which is ruptured while the other two have direct contact with the rm stem metal.Devices are still implanted although revision is planned after which devices will be sent to hospital pathology.For resolution of this case, it is of paramount importance to get more information about the involved metal ion levels because this is a very complex case with potentially four pathologies present to have influence on either metal ion elevation or adverse soft tissue effects and these are not necessarily all linked to each other.One big confounder is the patients right rm revision hip that without any question is a significant metal ion generator and as such could be responsible for the elevated metal ions.Also left hip cup impingement and approach related problems may have principal or secondary influence beyond the currently suspected taper corrosion problem of the left hip (at least by the surgeon treating the patient).Without further evidence, a relationship between the reported issues and the event failure mode is not readily evident and not even probable unless additional proof of contrary.Procedure related factors play a principal role in several of the potentially involved failure modes including dm cable problems, impingement due to cup malposition and surgical approach related problems and as such require further study and information for confirmation.Taper corrosion, if present at revision, requires adequate retrieval analysis with eds investigation for confirmation." conclusions: the exact cause of the event could not be determined based on the information provided.Additional information, such as the reported devices, operative reports, progress notes and pathology reports are needed to complete the investigation for determining the root cause.

Event Description

The customer has reported via the (b)(6), that a male patient, dob (b)(6) 1937, has allegedly suffered pseudotumour after undergoing surgery on his left hip in (b)(6) 2013.The customer has reported the following after carrying out an mri on the patient: "there is a sizeable trochanteric fluid collection at the left hip with thickened and irregular walls which extends into the capsule.The gluteal tendons are grossly intact though the anterolateral head of gluteus medius is a little ragged and there is mild atrophy of the gluteal musculature more proximally.The appearances would be suspicious for armd.".

• Brand Name: UNKNOWN_CORK_PRODUCT
• Type of Device: IMPLANT
• 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: 3973550
• MDR Text Key: 4750092
• Report Number: 0002249697-2014-02978
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 07/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_SHC
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/09/2014
• 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): Other
• Patient Age: 76 YR