MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH REVITAN, PROXIMAL PART, CONICAL, UNCEMENTED, 75, TAPER 12/14

Model Number N/A

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Bone Fracture(s) (1870); Pain (1994)

Event Date 05/21/2020

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: shell with cluster holes porous 60 mm o.D.Size mm for use with mm liners catalog#: 00875706001; lot#: 61297998.Bioloxâ® delta ceramic taper liner, size mm / 36 i.D.For use with 60 mm o.D.Size mm shell catalog#: 00877501436; lot#: unknown.Therapy date: (b)(6) 2020.The manufacturer received other source documents for review.The manufacturer did not receive the device for investigation.Where lot numbers were received for the 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.(b)(4).

Event Description

Patient was implanted on an unknown side and underwent revision surgery due to pain, metallosis and dislocation.

Manufacturer Narrative

Event description: it was reported that the patient was implanted with a revitan stem, a continuum cup and a biolox ceramic liner on an unknown date and underwent revision surgery on (b)(6) 2020 due to pain and an instable feeling of the joint.It was reported that metallosis was encountered intraoperatively.Review of received data: due diligence: no further due diligence required as all required information to support the conclusion is available or was already requested.Images: three undated images in pdf format have been received.One image shows an overview of retrieved implants consisting of a proximal revitan component with the connection pin of the distal revitan component, a revitan nut, a distal revitan component, a continuum shell with 3 cluster holes and an assembled polar screw, a biolox taper liner, a biolox femoral head and a screw.On the visible surfaces of the proximal revitan component no bone attachments can be seen.The connection pin seems highly polished with blackish discoloration at the distal end.In addition, the pin seems slightly tilted when comparing the pin's longitudinal axis to the axis of the proximal revitan component.On the visible surfaces of the distal revitan component a few bone attachments can be seen.The continuum cup has some scratches on its rim.On the image it seems that the inner surface of the cup is abraded.Parts of the cup's anchoring surface is covered with red tissue.The biolox taper liner shows some black smeared material along the inner and the outer rim edges.As far as assessable, the articulation surface of the biolox delta head looks inconspicuous.On the image showing the top view of the proximal revitan component the pin seems decentralized.Scratches and indentations can be found on the rim next to the thread.Some black discolorations can be seen spread over the visible surfaces.Further, as far as assessable, the stem taper looks inconspicuous.The third image shows the connection pin of the distal revitan component still assembled with the proximal revitan component.The pin has some black discolorations and there seems to be black tissue within the gap between the pin and the wall of the proximal revitan component.Further, the wall of the proximal revitan component seems abraded.Based on the silver reflection of the medial wall of the component, it can be assumed that the medial wall just distally of the neck part is abraded.Patient data: (b)(6), male, born (b)(6) 1956, 102 kg, 185 cm, bmi: 29.8.Product evaluation: no product was returned due to missing patient consent; therefore, visual and dimensional evaluation could not be performed.Review of product documentation: device purpose: all involved devices are intended for treatment.Product compatibility: the compatibility check was performed from www.Productcompatibility.Zimmer.Com and showed that the product combination was approved by zimmer biomet.Dhr review: review of the device history records of the proximal and the distal revitan components identified no deviations or anomalies during manufacturing.Conclusion: it was reported that the patient was implanted with a revitan stem, a continuum cup and a biolox ceramic liner on an unknown date and underwent revision surgery on may 21st, 2020 due to pain and an instable feeling of the joint.Based on the provided images of the retrieved components a loosening of the connection pin within the distal revitan component could be identified.Further, the connection pin seems decentralized within the proximal revitan component and abrasion and indentations were seen at the distal wall of the proximal revitan component.Nevertheless, based on the unavailability of the complained products, a visual and a dimensional evaluation could not be performed.The quality records show that all specified characteristics of the distal and the proximal revitan components have met the specifications valid at the time of production.Therefore, the investigation did not identify a non-conformance or a complaint out of box (coob).Medical records such as x-rays, surgical reports, intraoperative images of the surgical site, office visit notes and laboratory reports have not been received, therefore, potential patient and/or procedure related factors remain unknown.Additionally, based on the lack of medical records the reported metallosis could not be assessed.In conclusion, due to the lack of medical records, based on the unavailability of the complained products and as the cause may be multifactorial, a specific root cause could not be identified.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

No change to previously reported event.

• Brand Name: REVITAN, PROXIMAL PART, CONICAL, UNCEMENTED, 75, TAPER 12/14
• Type of Device: REVITAN, PROXIMAL PART, CONICAL, UNCEMENTED
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 10128067
• MDR Text Key: 194320956
• Report Number: 0009613350-2020-00237
• Device Sequence Number: 1
• Product Code: LZO
• 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: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 11/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/31/2015
• Device Model Number: N/A
• Device Catalogue Number: 01.00401.075
• Device Lot Number: 2558470
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/04/2020
• 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 Weight: 102