MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH MODULAR DUAL MOBILITY INSERT; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL / POLYMER, NON-POROUS, CALC

Catalog Number 626-00-38D

Device Problem Material Erosion (1214)

Patient Problems Foreign Body Reaction (1868); Pain (1994); Metal Related Pathology (4530)

Event Date 02/02/2023

Event Type  Injury  

Manufacturer Narrative

Reported event: an event regarding abnormal ion level involving a mdm liner was reported.The event was not confirmed.Method & results: product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.Clinician review: no medical records were received for review with a clinical consultant.Product history review: could not be performed as the device lot details were not provided.Complaint history review: could not be performed as the device lot details were not provided.Conclusions: the event could not be confirmed as insufficient information was provided.Further information such as device identification and return, pre- and post-operative x-rays, primary operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If additional information become available to indicate further evaluation is warranted, this record will be reopened.Device not returned.

Event Description

It was reported by the patient's attorney as a result of a legal claim that allegedly on or about (b)(6) 2019, the patient underwent a right total hip replacement with stryker components.It is further alleged that three months after the right hip replacement, the plaintiff began to experience clicking of the joint, along with pain in her hip, groin and buttock area.Blood test revealed elevated chromium (1.0) and cobalt (7.3) levels as well as elevated esr (9) and crp (2.8) levels.Allegedly the patient was revised on an unknown date.

Manufacturer Narrative

Reported event: an event regarding wear (metallosis) and abnormal ion level involving a mdm liner was reported.Wear was confirmed through clinician review.Abnormal ion level was not confirmed.Method & results: -product evaluation and results: visual inspection, material analysis, functional and dimensional inspections could not be performed as the device was not returned.-clinician review: a review of medical records with a clinical consultant indicated "as described above, this product inquiry concerns a patient who underwent a primary total hip arthroplasty with a cobalt chrome head, mdm articulation, with an accolade ii femoral stem.The patient developed pain and within about two years was diagnosed with metallosis and required revision which was performed with a competitor product.I can confirm that the patient had the primary and revision procedure since i was able to review the operation report.The root cause of this event cannot be determined with certainty.The causes of metallosis are multi-factorial including surgical technique, specifically in the preparation or lack thereof, of the femoral head or acetabular liner prior to insertion on the trunnion and into the acetabular shell.Other factors include the patient's activity level and bmi, as well as implant factors." -product history review: review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.-complaint history review: there have been no other similar events for the lot referenced.Conclusions: a review of medical records with a clinical consultant indicated "as described above, this product inquiry concerns a patient who underwent a primary total hip arthroplasty with a cobalt chrome head, mdm articulation, with an accolade ii femoral stem.The patient developed pain and within about two years was diagnosed with metallosis and required revision which was performed with a competitor product.I can confirm that the patient had the primary and revision procedure since i was able to review the operation report.The root cause of this event cannot be determined with certainty.The causes of metallosis are multi-factorial including surgical technique, specifically in the preparation or lack thereof, of the femoral head or acetabular liner prior to insertion on the trunnion and into the acetabular shell.Other factors include the patient's activity level and bmi, as well as implant factors." 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

It was reported by the patient's attorney as a result of a legal claim that allegedly on or about (b)(6) 2019, the patient underwent a right total hip replacement with stryker components.It is further alleged that three months after the right hip replacement, the plaintiff began to experience clicking of the joint, along with pain in her hip, groin and buttock area.Blood test revealed elevated chromium (1.0) and cobalt (7.3) levels as well as elevated esr (9) and crp (2.8) levels.Allegedly the patient was revised on an unknown date.

• Brand Name: MODULAR DUAL MOBILITY INSERT
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL / POLYMER, NON-POROUS, CALC
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NA ; EI NA
• Manufacturer Contact: marisol santiago ; 325 corporate drive; centennial park, elstree; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 16452310
• MDR Text Key: 310337533
• Report Number: 0002249697-2023-00203
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103233
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/07/2024
• 2 Devices were Involved in the Event: 1 2

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: 01/31/2024
• Device Catalogue Number: 626-00-38D
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/02/2023
• Initial Date FDA Received: 02/28/2023
• Supplement Dates Manufacturer Received: 01/17/2024
• Supplement Dates FDA Received: 02/07/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/11/2019
• 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: 56 YR
• Patient Sex: Female