MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH REVITAN, DISTAL PART, STRAIGHT, UNCEMENTED, 18/140

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Toxicity (2333)

Event Date 05/21/2020

Event Type  Injury  

Manufacturer Narrative

Concomitant medical product: shell with cluster holes porous 60 mm o.D.Size mm for use with mm liners, item # 00875706001, lot # 61297998, revitan, proximal part, conical, uncemented, 75, taper 12/14, item # 0100401075, lot # 2558470, biolox delta, ceramic femoral head, m, 36/0, taper 12/14; item # 00877503602, lot # unknown, biolox delta ceramic taper liner, size mm / 36 i.D.For use with 60 mm o.D.Size mm shell, item # 00877501436, lot # unknown.The manufacturer did not receive x-rays, or other source documents for review.The device history records were reviewed and found to be conforming.The manufacturer did not receive the device for investigation.Additional information has been requested and is currently not available.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 an unknown side and experienced metallosis.The femur fractured while removing the distal revitan stem which was later fixed with femoral plate and cables.

Manufacturer Narrative

Event description: it was reported that a revision surgery of a revitan stem was performed on (b)(6), 2020.The connection pin was dissociated from the distal revitan component and therefore there was no way to attach any device to the distal revitan component for removal.A window distally of the stem was cut into the femur to push the stem out.During the attempt to push out the stem the femur fractured.A distal femur plate and cerclage wires were used to stabilize the fracture and a long cemented revision stem was implanted.A surgical delay of 3 hours was reported due to these intraoperative complications.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, of which all show the explanted components.Nothing relevant to the bone fracture can be seen on these images.- patient data: h.E., 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: this device is 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 identified no deviations or anomalies during manufacturing.Conclusion: it was reported that a revision surgery of a revitan stem was performed on (b)(6), 2020.The connection pin was dissociated from the distal component and therefore there was no way to attach any device to remove the distal revitan component.A window distally of the stem was cut into the femur to push out the stem.During the attempt to push out the stem the femur fractured.A distal femur plate and cerclage wires were used to stabilize the fracture and a long cemented revision stem was implanted.A surgical delay of 3 hours was reported due to these intraoperative complications.No medical records such as revision report, intraoperative images and x-rays have been received.The complained products have not been returned due to missing patient consent; therefore, visual and dimensional evaluation could not be performed.The quality records show that all specified characteristics 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).It can be assumed that the failure mode of the revitan stem was the beginning of the described sequence of events finally leading to the reported bone fracture and the surgical delay.The cause of the bone fracture itself may be multifactorial consisting of patient factors such as bone quality, comorbidities and procedure related factors such as strength and direction of the applied force.As it may be multifactorial and due to the lack of medical records describing the exact course of events a specific root cause could not be identified for the reported bone fracture.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, DISTAL PART, STRAIGHT, UNCEMENTED, 18/140
• Type of Device: REVITAN, DISTAL PART, STRAIGHT, UNCEMENTED, 18/140
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 10166840
• MDR Text Key: 195536078
• Report Number: 0009613350-2020-00262
• Device Sequence Number: 1
• Product Code: LPH
• 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: 11/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/30/2016
• Device Model Number: N/A
• Device Catalogue Number: 01.00405.118
• Device Lot Number: 2608669
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 63 YR