MAUDE Adverse Event Report: ZIMMER GMBH REVITAN®, PROXIMAL PART, CONICAL, UNCEMENTED, 95, TAPER 12/14; HIP PROSTHESIS

Model Number N/A

Device Problem Material Twisted/Bent (2981)

Patient Problems Failure of Implant (1924); Pain (1994)

Event Date 06/28/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).Source - foreign - switzerland.Medical products: revitan, distal part, straight, uncemented, 20/140 item#: 01.00405.120, lot#: unknown; durasul alpha inlay ii/32 item#: unknown, lot#: unknown; 32 biolox delta 32 l item#: unknown, lot#: unknown.Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

Event Description

It was reported that the patient underwent a revision surgery due to the loosening/bending of the connection proximal part.Due diligence is in progress for this complaint; to date no additional information or product has been received.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional and/or corrected information.The revitan stem with mounted cocr head was received for examination, together with a durasul inlay.Of note: the conical screw of the revitan stem was not returned; the durasul inlay was returned with a screw inserted on the surface; metal chips were gathered and returned.The revitan stem is disassembled between the connection pin and the proximal part.The cocr head and the durasul inlay are inconspicuous.A screw was screwed in the inlay, probably in the attempt to remove the inlay.The distal and proximal parts of the revitan stem show damages from the revision surgery in the form of scratches, nicks and areas where the material is deformed.The distal part shows signs of drilling coming from revision: most likely the metal chips were produced during removal procedure of the distal part while drilling.On the proximal part, close to the neck, is possible to find a polished area probably due to contact against the cerclage wire.No bone on-growth can be seen on the anchoring surface of the proximal component.Bone attachment can be found on the anchoring surface of the distal component.The press fit area on the proximal part shows signs of wearing: the wall is thinned probably due to the movement of the pin after the disassociation occurred.Review of the device history record identified no deviations or anomalies during manufacturing.Devices are used for treatment.Radiographs were provided and reviewed.Already in vivo it is possible to see that the proximal part on the right side is medially tilted.Upon investigation of the returned products, it is possible to conclude that the cause of the misalignment was due to disassembly of the proximal part from the connection pin.On the right shaft it is possible to identify a line of radiolucency on the lateral side.Returned product showed dissociation of the proximal part form the pin of the distal part, but no evidence of non-conformances was found that might have led to the reported issue.Review of the device history record identified no deviations or anomalies during manufacturing; therefore, it is not expected that the manufacturing process contributed to the reported issue.No information was provided on the surgical technique; therefore, it is not possible to assess the procedure used to implant the involved devices.With the available information a definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: REVITAN®, PROXIMAL PART, CONICAL, UNCEMENTED, 95, TAPER 12/14
• Type of Device: HIP PROSTHESIS
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer (Section G): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 15102106
• MDR Text Key: 296572230
• Report Number: 0009613350-2022-00394
• Device Sequence Number: 1
• Product Code: JDH
• UDI-Device Identifier: 00889024502994
• UDI-Public: (01)00889024502994(17)100630(10)2277641
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/30/2010
• Device Model Number: N/A
• Device Catalogue Number: 0100401095
• Device Lot Number: 2277641
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/24/2005
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE
• Patient Outcome(s): Hospitalization; Required Intervention