MAUDE Adverse Event Report: ZIMMER GMBH REVITAN, PROXIMAL PART, CYLINDRICAL, UNCEMENTED, 55, TAPER 12/14; N/A

Model Number N/A

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Failure of Implant (1924)

Event Date 03/25/2019

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: revitan, distal part, straight, uncemented, 14/140, item #: 0100405114, lot #: 2548595, cocr ball head 32, item # 14320620, lot # 2578776, durasul insert, item # unknown, lot # unknown.Review of available information.Various documents were received: implantation report, revision report, medical letters, radiological report, intraoperative pictures.Review of product data: the product combination was approved by zimmer biomet.All involved devices are intended for treatment.The quality records show that all specified characteristics have met the specifications valid at the time of production.Ncr review: no ncr with a potential correlation to the reported event was found.The investigation results did not identify a non-conformance or a complaint out of box (coob).Conclusion: the revitan stem was revised after 8 years and 4 months in vivo due to recurrent dislocations and high instability.Based on the information from the sales representative, during revision surgery the proximal part of the revitan stem could be removed by hand with the connection pin attached.The conical nut was unscrewed very easily from the connection pin with the help of the torque wrench.The connection pin could then be removed by hand from the proximal part of the revitan stem.The implantation report of (b)(6) 2010 indicated that the acetabular roof was deficient and was rebuilt with an allograft.The trochanter was rated as insufficient and after the implantation of the stem the remaining trochanter, comprising of several mobile pieces, was re-fixed with the help of several cerclage wires.The implantation report states that a very stable trochanter hold was achieved with simultaneous good restoration of the pre-tension of the abductor muscles.According to the medical letter of (b)(6) 2018 the cerclages were removed on (b)(6) 2011.Further, debridement as well as soft tissue closure over the osseous trochanteric defect was performed on (b)(6) 2011.The patient had a fall due to syncope in (b)(6) 2016.On the available x-ray follow-up from (b)(6) 2011 to (b)(6) 2019 it can be recognized that there is no bone visible lateral to the proximal two thirds of the proximal part of the revitan stem and part of the trochanter major is visible just above the prosthesis shoulder.More, lateral to the distal one third of the proximal part of the stem there is a gap followed by a thin bone portion.All the second views show a gap between the anterior and posterior side of the proximal part of the stem and the bone.In addition, the pelvis overview x-ray taken on (b)(6) 2012 exhibits a radiolucent line medially along the proximal part of the stem.Six months later the radiolucent line is more clearly recognizable and starting with (b)(6) 2013 a gap bordered on the bone side by a sclerotic area can be seen along the medial side of the proximal stem and proximal region of the distal stem.This gap seems to become larger over time in vivo.There is no recognizable change in the x-rays of (b)(6) 2017 as a result of the fall mentioned above.On the retrievals at hand, bone attachments could be observed on the distal part of the revitan stem but not on the proximal part.On the proximal part of the revitan stem polishing and some wear can be seen which could probably indicate movements between the part and the surroundings.Based on the above described findings, the proximal bone support of the revitan stem immediately after implantation surgery and during the time in vivo can be interpreted as suboptimal.It is assumed that the connection pin got loose from the distal part of the stem due to an overload at one point in time.After loosening, the connection pin could move inside the stem body and subside together with the proximal part.The subsidence led to contact between the face surfaces of the proximal and the distal part resulting in wear on both surfaces.Additionally, the load was no longer completely borne by the connection pin.The loosening of the pin resulted in slight wear on the inside of the distal part.This allowed a little by little tipping of the pin to medial, so that its distal end could touch the inside of the distal stem body and form an elliptical shaped slightly worn area on the lateral side and slight wear medially proximal.In addition, the taper connection between the connection pin and the proximal part of the stem became loose at one point in time.Because of the loosening of the taper connection, movements between the proximal part and the connection pin were possible.This resulted in slight wear on the inside of the proximal part (lateral proximal and medial distal) as well as on the cylindrical region of the connection pin.The distal press-fit region of the connection pin shows a mixture of polishing, smearing and corrosion.The first two phenomena are most probably concomitants.However, it remains unclear whether corrosion could have had an influence on the failure mode or is only a concomitant as well.During implantation of the revitan stem, the acetabular roof was deficient and was rebuilt with an allograft which was fixed with a kerboull cage.A polyethylene insert was cemented in the cage with an inclination of approximately 32°.The x-ray follow-up showed increasing radiolucent areas in the region of the allograft bone, a fractured screw and decreasing inclination of the polyethylene insert.This indicates loosening and migration of the acetabular component.This situation probably resulted in the recurrent dislocations of the prosthesis.It is unknown if the loosening of the connection pin contributed in any way to the dislocations.Based on the retrieval investigation and the received documentation, it can be assumed that the lack of the proximal bone support around the proximal part of the stem contributed to the loosening of the connection pin from the proximal and distal part of the stem.It remains unknown if and to which extent the acetabular situation and the fall of the patient in 2016 contributed to the loosening of the pin.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).The following report is associated with this event: 009613350-2019-00245.

Event Description

It was reported that there was a revision surgery due to loosening of the pin of a revitan distal stem.Attempts to obtain additional information have been made; however no more is available at this point.

• Brand Name: REVITAN, PROXIMAL PART, CYLINDRICAL, UNCEMENTED, 55, TAPER 12/14
• Type of Device: N/A
• 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: 9871209
• MDR Text Key: 196441936
• Report Number: 0009613350-2020-00147
• Device Sequence Number: 1
• Product Code: LZO
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/31/2015
• Device Model Number: N/A
• Device Catalogue Number: 01.00402.055
• Device Lot Number: 2540154
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/12/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/22/2010
• 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 Weight: 62