MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH SULOX, HEAD, M, 32/0, TAPER 12/14

Model Number N/A

Device Problem Noise, Audible (3273)

Patient Problem Limited Mobility Of The Implanted Joint (2671)

Event Date 06/18/2020

Event Type  Injury  

Manufacturer Narrative

The manufacturer received other source documents for review.As no lot number was provided, the device history records could not be reviewed.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.(b)(4).

Event Description

Patient was implanted on the left side and started experiencing issues with mobility and rubbing noises.

Manufacturer Narrative

Additional information which was received on aug 19, 2020.This follow-up report is being filled to relay additional information, which was unknown at the time of the previous medwatch.D11- medical product: dural alpha insert neutr jj/32; item# 0100013410; lot#2739859; allofit alloclassic shl 54/jj; item#00000004246; lot#2779742; the manufacturer received surgical reports and x-rays for review.Should additional information become available and / or the device(s) be returned for evaluation 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

Patient was implanted on the left side and started experiencing issues with mobility and rubbing noises.

Manufacturer Narrative

Investigation results were made available.Additional: d4, d11, h2, h6.Correction: b4, b5, d10, g4, g7, h3, h10.Event description: it was reported that a patient was implanted with a sulox head on (b)(6), 2015, which was revised on (b)(6), 2020 due head fracture.Review of received data: x-rays: one undated ap pelvis overview has been received.Radiologically, visible head fracture, one fracture fragment is dislocated into the joint space.Images: a total of 6 product images have been received showing the broken sulox head and the worn polyethylene insert.The results of the image review are consistent with the findings of the visual examination.Please refer to the visual examination for more details.Surgical report: implantation report (b)(6), 2015: diagnosis: coxarthrosis left treatment: cementless htep left (allofit shell 54mm, durasul inlay 32, sulox head 32/m and cementless bicontact stem 14) description of procedure: no intraoperative complications noted.Revision report (b)(6), 2020 and information from surgeon's letter to bfarm: diagnosis: ceramic head fracture left htep treatment: removal of head fragments, replacement of inlay and ceramic head anamnesis: on (b)(6), 2020 the patient had fallen with the bicycle, he injured his left shoulder but had no complaints in the area of the hip joint.On (b)(6), 2020 the patient felt a crunch in his hip while getting up from a low couch and subsequently could no longer put weight on his hip.Radiologically, several fragments of the femoral head in the area of the hip joint.Description of procedure: mis approach.Three large and many small ceramic pieces are removed or rinsed out with jet lavage.The surface of the insert is scratched.The cup is clean.Insertion of a new allofit insert.Placement of an xl merete adapter on the cone and a 32 mm diameter ceramic biobrane.The postoperative x-ray control no longer shows any ceramic fragments.Product evaluation: visual examination: the polyethylene insert and three head fragments were received for examination.On the outer surface of the polyethylene, there are two imprints from the spikes of the shell.In addition, there is a cannulation of a screw.The articulation surface shows many scratches, indentations and inclusions of metal and ceramic particles.There is a screw hole in the articulation surface of the insert that was drilled during revision to remove the insert from the shell.The three ceramic fragments do not add up to a complete head.There is some metal smearing in the form of black dots and lines on the articulating surface.In addition, there is an almost perfect square on the articulation surface created by a juxtaposition of many small dot-shaped impacts in a line.The head taper shows circumferential metal smears transferred from the stem taper.These circumferential marks occur close to the bottom surface of the head, which also shows metal smearing.Review of product documentation: device purpose: all involved devices are intended for treatment.Product compatibility: the product combination was not approved by zimmer biomet because the bicontact stem is not a zimmerbiomet product.Dhr review: review of the device history records identified no deviations or anomalies during manufacturing.Instruction for use (ifu): 1.1 general instructions: zimmer has not tested the safety or effectiveness of these devices for use in combination with non-zimmer products or components.If surgeons elect to assemble and implant a construct that includes components not manufactured or distributed by zimmer, they do so in reliance on their own clinical judgment and should so inform their patients.Only authorized combinations should be used.It is the responsibility of the user to make sure that the systems are compatible.1.1 special instructions for hip implants: reliable seating of femoral cone-ball head combinations is only possible if the surface of the ball-head cone and the surface and structure of the femoral stem cone are intact and sound.It is absolutely essential that the outer cone of the femoral stem fit the inner cone of the ball head.2.4 side effects: implants, implant parts and instruments can fracture.Conclusion: it was reported that the patient was implanted on (b)(6), 2015 with an allofit shell, durasul alpha insert, sulox head and bicontact stem.On (b)(6), 2020, the patient had fallen on a bicycle, injured his left shoulder, but had no complaints in the hip joint area.Six weeks later, on (b)(6), 2020, the patient felt a crunch in his hip when getting up from a low couch.The subsequent radiological check revealed a fracture of the femoral head with fragments of the femoral head in the area of the hip joint.The fractured head was revised on (b)(6), 2020.Review of the implantation report revealed that the sulox head was mounted on a non-zimmer biomet stem.As stated in the instruction leaflet for endoprostheses supplied with the sulox head, the combination with a non-zimmer biomet device is considered an off-label use.The safety and effectiveness of this unapproved combination has not been tested.Visual examination shows metal smearing in the form of circumferential lines parallel to the head bottom, which also shows metal smearing.Based on these circumferential lines, it can be assumed that the stem taper had a tight fit in the head taper until the head fracture and the metal smearing at the head bottom occurred only after the head fracture.The quality records show that all specified characteristics of the sulox head have met the specifications valid at the time of production.Therefore, the investigation did not identify a nonconformance or a complaint out of box (coob).The examination performed suggests that an incompatibility of the stem and head taper and/or the patient's bicycle fall led or contributed to the head fracture.However, an exact cause could not be determined.The need for corrective measures is not indicated and zimmer switzerland manufacturing gmbh considers this case as closed.Zimmer biomet's reference number of this file is (b)(4).

Event Description

Investigation has been completed.

• Brand Name: SULOX, HEAD, M, 32/0, TAPER 12/14
• Type of Device: SULOX, HEAD, M, 32/0, TAPER 12/14
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 10272278
• MDR Text Key: 199711561
• Report Number: 0009613350-2020-00317
• Device Sequence Number: 1
• Product Code: LZO
• 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,Followup
• Report Date: 01/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 17.32.06
• Device Lot Number: 2773687
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Weight: 95