MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN_22MM CHROME-COBALT HEAD; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number UNK_JR

Device Problem Insufficient Information (3190)

Patient Problems Ossification (1428); Inflammation (1932); Injury (2348); Osteolysis (2377); Reaction (2414)

Event Date 02/07/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

This pi is for the patient's right hip construct.As reported in medwatch report # mw5092931: "on the right side, she has an osteonics omni flex stem with a 22mm chrome-cobalt on plastic articulation, which was implanted on (b)(6) 1992.Both hips consist of cocr components, but historically, the [competitor devices in left hip] tend to be a more common source of cobalt liberation via taper corrosion.On (b)(6) 2016, her urine cobalt level was 10 mcg/l.On (b)(6) 2017, her whole blood level was 5.1 mcg/l and urine level was 25 mcg\l.On (b)(6) 2018, her whole blood cobalt level was 4.0 mcg/l and urine cobalt level was 28 mcg/l.Given her age, she is undergoing cobalt chelation with n-acetyl cysteine in lieu of attempting revision surgery.On (b)(6) 2020, her blood cobalt level was 3.4 mcg/l and her urine cobalt level was 21 mcg/l.".

Manufacturer Narrative

Reported event: an event regarding abnormal ion level involving an unknown 22mm chrome-cobalt head was reported.The event was confirmed based on medical review.Method & results: device evaluation and results: not performed as product remains implanted.Clinician review: a review of the provided medical records and x-rays by a clinical consultant indicated:review of these records confirm advanced polyethlene wear in a tha implanted 28 years ago.The patient also had elevated cobalt levels in both blood and urine.These elevated levels may be related to the femoral head articulating with the acetabular shell but they could also be related to taper corrosion in the contralateral hip.It could also be a combination of both.Device history review: could not be performed as lot code information was not provided.Complaint history review: could not be performed as lot code information was not provided.Conclusion: it was reported that patient had abnormal ion level.The event was confirmed based on medical review.A review of the provided medical records and x-rays by a clinical consultant indicated:review of these records confirm advanced polyethlene wear in a tha implanted 28 years ago.The patient also had elevated cobalt levels in both blood and urine.These elevated levels may be related to the femoral head articulating with the acetabular shell but they could also be related to taper corrosion in the contralateral hip.It could also be a combination of both.The exact cause of the event could not be determined because insufficient information was provided.Additional information including operative reports, progress notes are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.

Event Description

This pi is for the patient's right hip construct.As reported in medwatch report # mw5092931: ".On the right side, she has an osteonics omni flex stem with a 22mm chrome-cobalt on plastic articulation, which was implanted on (b)(6) 1992.Both hips consist of cocr components, but historically, the [competitor devices in left hip] tend to be a more common source of cobalt liberation via taper corrosion.On (b)(6) 2016, her urine cobalt level was 10 mcg/l.On (b)(6) 2017, her whole blood level was 5.1 mcg/l and urine level was 25 mcg\l.On (b)(6) 2018, her whole blood cobalt level was 4.0 mcg/l and urine cobalt level was 28 mcg/l.Given her age, she is undergoing cobalt chelation with n-acetyl cysteine in lieu of attempting revision surgery.On (b)(6) 2020, her blood cobalt level was 3.4 mcg/l and her urine cobalt level was 21 mcg/l." update as per medical review: review of these records confirm advanced polyethlene wear in a tha implanted 28 years ago.The patient also had elevated cobalt levels in both blood and urine.These elevated levels may be related to the femoral head articulating with the acetabular shell but they could also be related to taper corrosion in the contralateral hip.It could also be a combination of both.

• Brand Name: UNKNOWN_22MM CHROME-COBALT HEAD
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 9859680
• MDR Text Key: 184919676
• Report Number: 0002249697-2020-00574
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 06/02/2020

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_JR
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/25/2020
• Initial Date FDA Received: 03/20/2020
• Supplement Dates Manufacturer Received: 05/08/2020
• Supplement Dates FDA Received: 06/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 84 YR