MAUDE Adverse Event Report: ZIMMER GMBH REVITAN, DISTAL PART, STRAIGHT, UNCEMENTED, 20/140; UNKNOWN

Model Number N/A

Device Problems Break (1069); Connection Problem (2900)

Patient Problem No Information (3190)

Event Date 02/17/2016

Event Type  Injury  

Manufacturer Narrative

The manufacturer did not receive devices, x-rays, or other source documents for review.As no lot numbers were provided for the devices, the device history records could not be reviewed.The actual device reported in section d is not marketed in usa, but devices with similar characteristics are marketed in usa (i.E.Fitmore stem), and therefore this report was filed.A cause for this specific event cannot be ascertained from the information provided.Should additional information become available and an investigation result be available, that changes this assessment, an amended medical device report will be submitted.Zimmer's reference number of this file is (b)(4).

Event Description

It was reported that the patient was implanted an unknown revitan distal hip product on an unknown date.On (b)(6) 2016 the revitan broke at the connecting pin.The patient was revised on (b)(6) 2016.

Manufacturer Narrative

Device history records (dhr): the device manufacturing quality records indicate that the released components met all requirements to perform as intended.Trend analysis: no trend identified.The compatibility check was performed from www.Productcompatibility.Zimmer.Com and showed that the product combination was approved by zimmer biomet.Event summary: the revitan is broken at the connecting pin.Revision surgery was carried out on (b)(6) 2016.The morscherpressfit cup was left into patient.Investigation summary and root cause analysis the revitan stem was revised after 7 years and 1 month in vivo due to a fracture of the prosthesis.The connection pin of the revitan stem is fractured due to fatigue in the nonblasted area some millimeters below the proximal end of the distal stem part.The fracture origin is located on the lateral side.Macroscopically, no defects that could have favored or triggered the fracture were found on the fracture surfaces.On the proximal fracture part a semi circumferential stripe revealing mostly smeared metal and some isolated spots with signs of fretting could be observed.It is unknown if the observed signs of fretting developed already before the start of the fracture and are associated with it or developed exclusively as a concomitant.The extent of the metal smearing and its partial polishing could derive from the repetitive contact of the pin with the distal stem body after the pin fractured.This possibly led to the wear inside of the distal stem body which may have contributed to the metallosis found during the revision surgery.The received x-rays show possible radiolucent lines extended until approximately the distal third of the stem.Since there is no complete set of follow-up x-rays at hand it is not possible to evaluate the change process of the bony structure and / or the possible development of the observed radiolucent lines between implantation and revision surgery.The proximal part does not show any bone attachments while the distal third of the distal part features some bone attachments.In addition some line-like polishing can be observed on the medial and posterior side of the anchoring surface of the proximal part indicating possible loosening.Based on the bone ongrowth seen on the revised components, the polishing on the proximal stem part and the observation made from the x-rays it is assumed that the distal stem part was fixed in the distal third while the proximal part was probably loose.Therefore, it is hypothesized that the stem did not have sufficient proximal bone support which might have led to an overload of the connection pin finally resulting in the fracture.As the clinical history, the complete set of follow-up x-rays and information about the patient¿s mode of life are not available for evaluation it stays unknown if there might have been other influencing factors.Conclusion summary: based on the retrieval investigation and the received information the reason for the fracture stays unknown.The need for corrective measures is not indicated and zimmer (b)(4) considers this case as closed.Zimmer¿s reference number of this file is (b)(4).

Event Description

It has now been reported that, a patient was implanted a revitan, distal part, straight, uncemented in (b)(6) 2009 (exact date unknown) due to aseptic loosening of previous implanted stem.On (b)(6) 2016 the stem broke at the connectiong pin and was revised on (b)(6) 2016.

• Brand Name: REVITAN, DISTAL PART, STRAIGHT, UNCEMENTED, 20/140
• Type of Device: UNKNOWN
• 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: kevin escapule ; 1800 west center street; warsaw, IN 46580-0708 ; 8006136131
• MDR Report Key: 5494979
• MDR Text Key: 40149693
• Report Number: 9613350-2016-00470
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: SZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/30/2013
• Device Model Number: N/A
• Device Catalogue Number: 01.00405.120
• Device Lot Number: 2459186
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/22/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/09/2008
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 71 YR