MAUDE Adverse Event Report: ZIMMER GMBH ALPHA INSERT ME WITH RIM II/32

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Unspecified Infection (1930); Pain (1994)

Event Date 02/16/2015

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products - therapy date: (b)(6) 2015.The manufacturer received documents for review.The manufacturer did not receive the device for investigation./where lot numbers were received for the explanted devices, the device history records were reviewed and found to be conforming.A cause for this specific event cannot be ascertained from the information provided.As soon as supplemental information becomes available an updated report will be submitted.Zimmer biomet¿s reference number of this file is (b)(4).

Event Description

Patient was implanted on the unknown side and underwent revision surgery due to metallosis, elevated metal ion levels and infection.

Manufacturer Narrative

This follow-up report is being filled to relay investigation result.Additional and corrected information are filled in the following fields: dhr review: the device manufacturing quality records indicate that the released components met all requirements to perform as intended.Trend analysis: no trend considering the following event is identified: revision due to metallosis, infection.Event description: it was reported that the patient underwent primary left thr on (b)(6) 2009.Patient, on vacation in the year of 2012 had chills, a high fever and a red rash (erysipel - infektion) around his gluteal-area.Therefore, there were treatments on (b)(6) 2012, (b)(6) 2013, (b)(6) 2013, (b)(6) 2013, (b)(6) 2014, (b)(6) 2015 and (b)(6) 2015.There was a revision of the allofit cup and metasul-inlay on the (b)(6) 2015 due to metallosis.Review of received data: - for the investigation 3 x-rays in total (2 after the revision surgery and 1 after the primary surgery) were received.The ap view pelvis x-ray dated (b)(6) 2009 was recorded one week post-op.The quality of the x-ray is quite low to make exact evaluation, however, the components positioning of the left thr is deemed to be sufficient with 43 inclination angle.No abnormal issue observed.- primary surgery report dated (b)(6) 2009 is reviewed.No abnormalities were observed.Revision surgery report dated (b)(6) 2015: diagnose: metallosis due to metal on metal, left thr therapie: head-inlay revision no findings related to any failure types for the prosthesis components were indicated in the surgical report.Surgery was completed with implantation of alpha insert 36 (ref.(b)(4),lot 2780681), bioball delta ceramic-head 36 (ref.(b)(4),lot 7010889172/04), bioball adapter size 12/14 medium (ref.(b)(4),lot ms1405355).- legal document dated (b)(6) 2018 is reviewed.Patient experienced chills, a high fever and a red rash (erysipel - infection) around buttock, which was treated by an antibiotic treatment.No causes of the problem were found.Later on these problems showed themselves again.Therefore, there were treatments on (b)(6) 2012, (b)(6) 2013, (b)(6) 2013, (b)(6) 2013, (b)(6) 2014, (b)(6) 2015 and (b)(6) 2015.Hevay metal poisoning was suspected and blood results were done.On (b)(6) 2014 the blood test showed a cobalt value of 3.58 g / l with a standard value of <0.5 g /, therefore a value increased more than seven times.The blood test of 3.2.2015 revealed a cobalt value of 4.4g / dl, which is an increase of almost nine times the norm.Device analysis: no product was returned to zimmer biomet for in-depth analysis.Review of product documentation: - the compatibility check was performed and showed that the product combination was approved by zimmer biomet.- sterilization certificates of the components were reviewed and confirmed to be conforming to the sterilization specifications.Conclusion: blood test results confirm the high level of cobalt in the patient.No x-rays between the primary and revision surgeries were received in order to have a full picture of the events.Revision surgery report did not state any failures or damages related to the components.In this sense it is not possible to find a root cause for the reported metallosis.Review of the device history records for the products did not identify any deviations or anomalies related to the metallosis.Possible causes of the reported metallosis include 3rd body particles left between the head/liner or head/stem taper, dislocation/subluxation, frictional moments for ball heads, high patient activity, soft tissue laxity, increased ante/retro-version of the stem increasing joint loading, scratches on articulation surface from surgeons, patient with high body weight/bmi.It is not known to which extent these factors had a role.Due to absence of products for investigation we cannot comment further on this hypothesis.Sterilization certificates are reviewed.The sterilization certificates confirm that the products were sterilized according to the specifications.Single-use, sterilized devices manufactured or distributed by zimmer biomet are sterilized in accordance with fda regulations and iso standards to a sterility assurance level of 1.0 x 10-6 or better.Therefore, it is not suspected that the product caused or contributed to any patient infection.Moreover, infection was reported to be observed 3 years after the primary surgery.Thus, it can be excluded that an unsterile device caused the infection.However, the ifu for endoprosthesis d011500200 states that early or late infections are possible consequences of an implant and should be considered when implanting zimmer biomet devices.Nevertheless, possible causes of the infection include contamination of the product during op, damage of the packaging during transportation, resterilization of the device and reuse of the device which is only intended for single use.However, no possible risks could be identified regarding the osteolysis around the stem.Based on the available information, an exact root cause could not be determined.The need for corrective measures is not indicated and zimmer gmbh considers this case as closed.Zimmer biomet¿s reference number of this file is (b)(4).

Event Description

Please refer to report 0009613350-2018-01193.

• Brand Name: ALPHA INSERT ME WITH RIM II/32
• Type of Device: ALPHA INSERT
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 8146615
• MDR Text Key: 129780908
• Report Number: 0009613350-2018-01193
• Device Sequence Number: 1
• Product Code: KWB
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Type of Report: Initial,Followup
• Report Date: 04/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/31/2011
• Device Model Number: N/A
• Device Catalogue Number: 01.00010.909
• Device Lot Number: 2314076
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 43 YR