MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN MODULAR STEM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number UNK_SHC

Device Problems Device Appears to Trigger Rejection (1524); Device-Device Incompatibility (2919)

Patient Problems Foreign Body Reaction (1868); Inflammation (1932); Renal Failure (2041); Renal Impairment (4499)

Event Date 12/10/2020

Event Type  Injury  

Manufacturer Narrative

It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.

Event Description

Patient who had a hip replacement in (b)(6) 2011.Since then, the patient has had a regular dosage of cobalt and chrome in his blood with levels that increase each year.Patient referred in (b)(6) 2020 to a nephrology consultation for renal failure.The analysis of the assessments shows a progressive deterioration of the renal function which goes from 95ml/min in 2013 to 24ml/min end 2020.A kidney biopsy was carried out and found levels of this chromium (1000 times normal) and cobalt very increased it is concluded to a chronic kidney disease on chronic cobalt and chromium intoxication linked to his prosthesis.Patient's current condition: chronic kidney disease stage 4.Due to the speed of deterioration, very high risk in the months/years to come to the end stage of chronic kidney disease and therefore require dialysis.Actions taken in the health care institution for the care of the patient : removal of the prosthesis during programming.Information and preparation of the patient for dialysis in the coming months.

Manufacturer Narrative

Reported event: an event regarding abnormal ion level involving a rejuvenate modular device was reported.The event was confirmed.Method & results: -device evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device remained implanted.-device history review: review of device history records could not be performed as the reported device was not properly identified.-complaint history review: a search of the complaint databases could not be performed as the reported device was not properly identified.Similar events have occurred for the rejuvenate modular product family.These events were determined to be associated with ra.Conclusions voluntary recall ra 2012-067 was initiated for abgii and rejuvenate modular stems and necks due to the potential risks associated with these devices.The reported abnormal ion level is considered to be under the scope of this recall.No further investigation is required.H3 other text : device not returned.

Event Description

Patient who had a hip replacement in (b)(6) 2011.Since then, the patient has had a regular dosage of cobalt and chrome in his blood with levels that increase each year.Patient referred in (b)(6) 2020 to a nephrology consultation for renal failure.The analysis of the assessments shows a progressive deterioration of the renal function which goes from 95ml/min in 2013 to 24ml/min end 2020.A kidney biopsy was carried out and found levels of this chromium (1000 times normal) and cobalt very increased it is concluded to a chronic kidney disease on chronic cobalt and chromium intoxication linked to his prosthesis.Patient's current condition: chronic kidney disease stage 4.Due to the speed of deterioration, very high risk in the months/years to come to the end stage of chronic kidney disease and therefore require dialysis.Actions taken in the health care institution for the care of the patient : removal of the prosthesis during programming.Information and preparation of the patient for dialysis in the coming months.

• Brand Name: UNKNOWN MODULAR STEM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 11172627
• MDR Text Key: 227057326
• Report Number: 0002249697-2021-00118
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial,Followup
• Report Date: 04/28/2021

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_SHC
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/22/2020
• Initial Date FDA Received: 01/14/2021
• Supplement Dates Manufacturer Received: 04/26/2021
• Supplement Dates FDA Received: 04/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention