MAUDE Adverse Event Report: STRYKER GMBH UNKNOWN POLYMER FINGER JOINT PROSTHESIS SIZE 3 AT LONG 20MM SCREW; IMPLANT

Catalog Number UNK_SEL

Device Problems Loose or Intermittent Connection (1371); Loss of Osseointegration (2408); Device Dislodged or Dislocated (2923)

Patient Problems Debris, Bone Shedding (1803); Nerve Damage (1979); Pain (1994); Loss of Range of Motion (2032)

Event Date 01/01/2018

Event Type  Injury  

Manufacturer Narrative

Upon completion of investigation, additional information will be provided in a supplemental report.

Event Description

Patient reported through a medwatch (mw5084860) that, after implantation of finger joints, they experienced dislocation, loosening, bone matter degeneration, loss of mobility, and underwent revision surgery.

Manufacturer Narrative

Correction: (results & conclusion).The reported event could be confirmed only based on x-rays, since the device was not returned for evaluation.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.However, the x-rays sent were reviewed by stryker¿s medical expert, and his clinical opinion about this case is the following: "so far, we have a couple of x-rays showing a left hand after pip-joint replacement of the digg.Ii, iii and iv.The index finger additionally shows an arthrodesis supported with a screw in the dip-joint.The patients also describes failure as a result of loosening and that revision surgery was performed.The described nerve damage and loss of sensation is related to the surgery and not related to the implant.Regarding the srpip: while the distal component is made of a cocr-alloy, the proximal component is made from titanium with a polyethylene-inlay.From biocompatibility analysis we know that titanium has a very good biocompatibility and the surface shall support the bony ingrowth of the implant.As there is no sufficient clinical support and no appropriate clinical results regarding the success of the treatment the device is classified as a humanitarian device.Every joint replacement in the human body consists of at least one metal component and after the ingrowth of the implant this is not a problem, but a necessity.Otherwise, under constant mechanical load, implant failure would appear soon.Without preoperative assessment of the patient and preoperative x-rays, a sound judgement on the preoperative clinical-radiological situation of the patient is not possible.And without a preoperative assessment it is not possible to evaluate to what extend the implant may have contributed to the failure.From the x-ray (unfortunately it is not clear how old, respectively how long after implantation they are taken-three months, if the replacement took place in january 2016) we see, that the choice of the implant size seems to be too small.There is spongious bone around both parts of the prosthesis, especially at the pip of dig iii.This may have contributed to early loosening, or to be more precise, the non-consolidation of the joint replacement.It looks, as if the implant did not fit and thus did not consolidate in the first place.Desintegration of the implant may also take place if there is an allergy to the components present.This seems rather unlikely, as this usually leads to wound healing disturbances in implants so close to the skin and surface of the body.Due to the good biocompatibility, allergy is pretty rare for titanium and also for other implants after surface treatment.If instability of the joint was present before the operation, this would have been a contraindication against joint replacement, as well as pre-existing swan neck deformity is.Summarized, from my point of view the indication for the first implantation is critical and in this case the treatment may not have been indicated properly.But as i mentioned before i am not able to give a sound judgement on this, as it is a clinical [.] decision, together with the x-rays.From the diagnosis and what the patient told us i would say that the joint was too instable to choose the joint replacement as the therapy.Instability prolonged and made the additional following interventions necessary.From what we find in the op tech and what one can find in the literature stability of the joint is the most important criterion to the op.Joint replacement in the finger joints is reserved for a small number of patients who must be selected very carefully.In addition, a very comprehensive explanation with reference to a possible failure of the therapy and the resulting consequences is indispensable.As a result it has to be said, that the surgeon is responsible for this, because the information material makes this very clear." therefore, this case is classified as a user related issue.A review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.If any further information is provided, the investigation report will be updated.

Event Description

Patient reported through a medwatch (mw5084860) that, after implantation of finger joints, they experienced dislocation, loosening, bone matter degeneration, loss of mobility, and underwent revision surgery.

Event Description

Patient reported through a medwatch (mw5084860) that, after implantation of finger joints, they experienced dislocation, loosening, bone matter degeneration, loss of mobility, and underwent revision surgery.

Manufacturer Narrative

Correction: sections concomitant medical products and device evaluated by mfr.The reported event could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.A review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.If any further information is provided, the investigation report will be updated.Device disposition unknown.

Manufacturer Narrative

Correction: section d6 (date of implant).Addition of h6 codes.

Event Description

Patient reported through a medwatch (mw5084860) that, after implantation of finger joints, they experienced dislocation, loosening, bone matter degeneration, loss of mobility, and underwent revision surgery.

• Brand Name: UNKNOWN POLYMER FINGER JOINT PROSTHESIS SIZE 3 AT LONG 20MM SCREW
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 8520625
• MDR Text Key: 142192311
• Report Number: 0008031020-2019-00357
• Device Sequence Number: 1
• Product Code: MPK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNK_SEL
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention