MAUDE Adverse Event Report: ZIMMER GMBH REVITAN, PROXIMAL PART, CYLINDRICAL, UNCEMENTED, 65, TAPER 12/14

Model Number N/A

Device Problem Disassembly (1168)

Patient Problem No Information (3190)

Event Date 01/16/2018

Event Type  Injury  

Manufacturer Narrative

The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.X-ray was received and will be part of ongoing investigation.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).Note: first revision case (cls stem): (b)(4).Implant date taken from second revision case (stem generic): (b)(4).Warsaw complaint was captured under : (b)(4).

Event Description

It was reported that the patient had a revision surgery approximately eleven years post implantation due to proximal part disassociated from stem.Attempts to obtain additional information have been made; however, no more is available.

Manufacturer Narrative

This followup report is being filled to relay investigation result.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: loosening/dislocation.Event description: it has been reported that a revitan system was revised due to dislocation of the proximal part.Review of received data: one xray has been received, taken prior to the revision surgery.The following xray assessment of the implanted revitan system (distal straight uncemented 18/140, proximal cylindrical uncemented 65 taper 12/14, metasul head d28/+4 ¿l¿ taper 12/14) was performed by a hcp: according to the xray the proximal stem implant is medially tilted by around 18°.There is no visible evidence of a pin breakage, even though a breakage is highly likely, as in the middle of the screw nut a circular radioopaque structure is visible, comparable to the proximal part of the connection pin.The screw nut, located at the height of the cranial rim of the proximal stem implant, appears in a 90° tilted position.In the distal part of the proximal stem implant an intact cerclage is seen, another two intact cerclages are seen around the distal stem implant.From a radiological perspective, a possible damage/abrasion of the proximal part is due to the position of the two parts not visible.But, radiological indication is given that osteolytic osseous structures are present next to the implant at the height of the connection between the proximal and the distal part as well as in the area of the distal stem implant.A possible osteolytic bone alteration next to the proximal implant in the medial area of the calcar is visible.An additional zone of osteolysis appears in the middle of the distal stem implant.Periimplant seam formation is visible in the area of the distal stem implant (medial and lateral) between the most distal cerclage and the connection of the two stem implant parts.Last, a possible fracture of the lesser trochanter fragment is seen.Device analysis: no product was returned to zimmer biomet for indepth analysis.Review of product documentation: all proximal revitan components are compatible with all distal ones.Root cause analysis: root cause determination using sap rmw: aseptic loosening of stem, bone fracture due to incorrect distribution of load due to design (e.G.Stress shielding) not possible, as a systematic issue with design would have been detected as part of the issue evaluation assessment aseptic loosening of stem, bone fracture due to insufficient primary stability due to design not possible, as a systematic issue with design would have been detected as part of the issue evaluation assessment aseptic loosening of stem due to insufficient secondary stability possible, as the investigation suggests loosening of the proximal implant component.Abrasive wear, dislocation, metallosis, aseptic loosening of stem, implant breakage due to different thermal expansion of components not possible, as according to material compatibility specification sap the material has been tested.Further a systematic issue with material properties would have been detected as part of the issue evaluation assessment aseptic loosening of stem, abrasive wear due to movement of implant part (proximal or distal) leads to wear possible, as the investigation suggests loosening of the proximal implant part.Even though, the xray evaluation did not show evidence of abrasion / wear, some degree of abrasion and wear can be expected.Dislocation, metallosis, aseptic loosening of stem due to wrong design of pin leading to failure of connection between proximal and distal part and subsequent release of wear particles (e.G.Fretting) not possible, as a systematic issue with design would have been detected as part of the issue evaluation assessment implant breakage, bone fracture due to wrong planning template used / misinterpretation of the xray templates regarding center of rotation/leg length/offset possible, even though the xray evaluation did not reveal a wrong center of rotation/leg length or offset this cannot be completely excluded on the basis of this single xray received.Implant breakage/ dislocation due to wrong position of distal femoral component/ wrong antetorsion for proximal part chosen possible, even though the xray evaluation suggests a firm seat of the distal component, a slightly inappropriate antetorsion of the proximal component cannot be excluded from the xray received.Implant breakage due to proximal and distal component not firmly tightened possible, as the proximal part tilted (dislocated) an inappropriate tightening cannot be excluded.Implant breakage/ dislocation due to wrong position of assembled femoral component/ wrong antetorsion for proximal part chosen possible, even though the xray evaluation suggests a firm seat of the distal component, a slightly inappropriate antetorsion of the proximal component cannot be excluded from the xray received.Implant dislocation/ loosening due to selection of wrong components not possible, as the xray evaluation did not reveal the selection of wrong components.Implant dislocation/loosening due to inappropriate information on packaging label or not legible packaging label leads to incorrect use of implant possible, as the investigation suggests that the proximal implant component loosened.Aseptic loosening of stem due to surgeon unfamiliar with implantation technique of this stem design (early stability, incorrect use etc.) possible, as the investigation suggests that the proximal implant component loosened.Conclusion: based on the received xray the complaint could be confirmed.The revitan® stem system was revised after approximately 11 years in vivo, most likely, due to loosening of the proximal part.The xray evaluation showed that the proximal part was tilted by around 18°.There was no visible evidence of a pin breakage, even though a breakage appears highly likely, as in the middle of the screw nut a circular radioopaque structure is visible, comparable to the proximal part of the connection pin.The screw nut is located at the height of the cranial rim of the proximal stem implant and appears in a 90° tilted position.From a radiological perspective, a possible damage/abrasion of the proximal part is due to the position of the two parts not visible.But, radiological indication is given that osteolytic osseous structures are present next to the implant at the height of the connection between the proximal and the distal part as well as in the area of the distal stem implant.A possible osteolytic bone alteration next to the proximal implant in the medial area of the calcar is visible.An additional zone of osteolysis appears in the middle of the distal stem implant.Periimplant seam formation is visible in the area of the distal stem implant (medial and lateral) between the most distal cerclage and the connection of the two stem implant parts.Last, a possible fracture of the lesser trochanter fragment is seen.On the basis of the xray evaluation the most likely course of events is described below, nevertheless, as the implants have not been received for investigation, some variations cannot be excluded.Most likely, the proximal part of the implant system loosened, leading to abrasion of the medial wall of the proximal part at the connection to the distal part on the one hand and to abrasion at the point of contact of the lateral wall of the proximal part and the screw nut on the other hand.Therefore, we expect the medial wall of the proximal part to be highly reduced or even completely worn down.This loosening/abrasion allows the proximal part to tilt out of axis as implied by the xray.Based on the tilting, the screw nut experiences unintended forces which may lead to a breakage of the connection pin (connection between proximal and distal part).A potential breakage occured most likely at the cutin of the connection pin, as this is the area holding the smallest crosssection of the pin.After a pin fracture the screw nut including the remaining part of the proximal pin may freely move, which would explain the location of the screw nut and the proximal pin part at the cranial rim of the proximal implant part.The quality records show that all specified characteristics (material, dimensions, surface, etc.) have met the specifications valid at the time of production.Therefore, based on the given information and the results of the investigation, we identified the loosening of the proximal implant part as the most likely root cause, however, an exact root cause for the loosening could not be found.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).

• Brand Name: REVITAN, PROXIMAL PART, CYLINDRICAL, UNCEMENTED, 65, TAPER 12/14
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 7265964
• MDR Text Key: 99883121
• Report Number: 0009613350-2018-00243
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/31/2012
• Device Model Number: N/A
• Device Catalogue Number: 01.00402.065
• Device Lot Number: 2393561
• Other Device ID Number: 00889024503014
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/16/2018
• Initial Date FDA Received: 02/13/2018
• Supplement Dates Manufacturer Received: 08/30/2018
• Supplement Dates FDA Received: 09/07/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: ECHO B-MTRC, ITEM# 192807, LOT# 2391876; REVITAN DISTAL, ITEM# 0100405118, LOT# 2383693; ECHO B-MTRC, ITEM# 192807, LOT# 2391876; REVITAN DISTAL, ITEM# 0100405118, LOT# 2383693
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 79 YR