MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 28MM +4 V40 TAPER VIT HEAD; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	6260-5-228
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Inflammation (1932); Reaction (2414)
Date of Event	12/28/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.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 or Problem Description
Pharmacist from the hospital reported the following event : " involvement of the medical device in the occurrence of metallosis: chrome-cobalt poisoning with cardiopathy on prosthesis placed in 2014.".
Additional Manufacturer Narrative
An event regarding abnormal ion level and metallosis involving a metal head was reported.The event of abnormal ion level was confirmed by clinician review but the event of metallosis 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.-medical records received and evaluation: a review of the provided medical information by a clinical consultant indicated: a severe corrosion problem 5-years after a left hip abg revision hip arthroplasty with extremely high systemic cobalt and chrome levels has caused a symptomatic cardiac myopathy and possibly as well a pulmonary embolus a few months earlier.Chelation therapy using edta has reduced systemic metal ion levels as well as clinical symptoms significantly although parameters were still far from normal in (b)(6) 2018.Left hip exchange using a two- stage procedure was proposed and scheduled for (b)(6) 2018, but there is no information available about findings or the actual procedure performed.As such is the left hip source of the metal ions certain as cause for the cardiac problems although actual type or cause of corrosion problem cannot be established due to complete lack of relevant information.Product history review: a review of the device manufacturing records indicate that all devices accepted into final stock were free from discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusions: a severe corrosion problem 5-years after a left hip abg revision hip arthroplasty with extremely high systemic cobalt and chrome levels has caused a symptomatic cardiac myopathy and possibly as well a pulmonary embolus a few months earlier.Chelation therapy using edta has reduced systemic metal ion levels as well as clinical symptoms significantly although parameters were still far from normal in (b)(6) 2018.Left hip exchange using a two- stage procedure was proposed and scheduled for (b)(6) 2018, but there is no information available about findings or the actual procedure performed.As such is the left hip source of the metal ions certain as cause for the cardiac problems although actual type or cause of corrosion problem cannot be established due to complete lack of relevant information.
Event or Problem Description
Pharmacist from the hospital reported the following event: " involvement of the medical device in the occurrence of metallosis: chrome-cobalt poisoning with cardiopathy on prosthesis placed in 2014.".

• Brand Name: 28MM +4 V40 TAPER VIT HEAD
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 8273819
• Report Number: 0002249697-2019-00317
• Device Sequence Number: 16568753
• Product Code: JDI
• UDI-Device Identifier: 07613327012897
• UDI-Public: 07613327012897
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K173499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 07/02/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2021
• Device Catalogue Number: 6260-5-228
• Device Lot Number: 46752403
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/28/2018
• Supplement Date Received by Manufacturer: 06/06/2019
• Initial Report FDA Received Date: 01/24/2019
• Supplement Report FDA Received Date: 07/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 72 YR