MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN 40 +4 HEAD; HIP IMPLANT

Catalog Number UNK_REC

Device Problem Insufficient Information (3190)

Patient Problems Edema (1820); Pain (1994)

Event Date 06/10/2015

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.Not available.

Event Description

Patient's left hip was revised due to pain with mri evidence of pseudotumor.Mri showed pseudobursa.Co/cr levels: 1.0/<41.

Manufacturer Narrative

An event regarding altr and abnormal ion levels involving an unknown implant head was reported.The event was not confirmed.Method & results: -device evaluation and results: a visual, dimensional and functional inspection was not performed as the device was not returned for evaluation.-medical records received and evaluation: a review by a clinical consultant noted: metal ion values are reported for most patients and several are clearly very much elevated above the considered risk levels for altr (adverse local tissue reactions) and as such may represent cases with altr including pseudotumor.The table lists 24 cases all together with various degrees of taper corrosion or catastrophic trunnion failure with pseudotumor.Two cases have really extreme metal ion values, the others are below the risk level considered by (b)(4) or hip society for altr and should be considered normal for an arthroplasty patient (up to 3-3,5 g/l), even though higher than for non-arthroplasty patients (up to 1 g/l).For this patient with pi 1217312, cobalt values were normal with 1 g/l while chrome was very much elevated with 41 g/l.This is a very strange combination, usually cobalt is elevated while chrome is normal due to chrome depletion in the device corrosion process.As such, this reverse ratio might suggest a different failure mode than just corrosion alone and requires more information for explanation which is currently not available.Similar uncertainty relates to the reported ¿pseudobursa¿.This is based upon mri findings without those being detailed.Mri can suggest altr but not prove this.Mri with arthroplasties is associated with a lot of issues and problems relating to proper diagnosis because the magnetic field of the mri is distorted by the metal mass of the implanted devices which makes proper interpretation very difficult.There is new software with metal artifact removal software to improve on this (mars mri) but even then a suspect diagnosis of altr requires verification by explant tissue histopathology.Without histological analysis this cannot really be verified.Conclusions: a review by a clinical consultant stated: the reported pseudobursa for this patient is not the same as pseudotumor.Bursa formation usually includes fluid accumulation which is clear sign of an arthroplasty ¿irritation state¿ but just by itself provides no diagnostic clues and thus also requires more contextual information for understanding.As such can case pi 1217312 not be solved with the available information but requires more relevant information for better understanding of the case.The exact cause of the event could not be determined because insufficient information was provided.Further information such as return of device, operative reports, x-rays, pathology reports, patient history & follow-up notes are needed to investigate this event further.If additional information and/or device become available, this investigation will be reopened.

Event Description

Patient's left hip was revised due to pain with mri evidence of pseudotumor.Mri showed pseudobursa.Co/cr levels: 1.0/<41.

• Brand Name: UNKNOWN 40 +4 HEAD
• Type of Device: HIP 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: keyla colon ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5773165
• MDR Text Key: 48917193
• Report Number: 0002249697-2016-02195
• Device Sequence Number: 1
• Product Code: JDG
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 06/10/2016

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 Catalogue Number: UNK_REC
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/10/2016
• Initial Date FDA Received: 07/06/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/16/2016
• 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): Hospitalization; Required Intervention