MAUDE Adverse Event Report: STRYKER GMBH PROXIMAL INTERPHALANGEAL IMPLANT, SIZE 4; SEMI-CONSTRAINED METAL/POLYMER FINGER JOINT PROSTHESIS

Catalog Number SRPIP4

Device Problems Loose or Intermittent Connection (1371); Positioning Problem (3009)

Patient Problem Pain (1994)

Event Date 08/01/2015

Event Type  Injury  

Manufacturer Narrative

Device will not be returned.If additional information becomes available it will be provided on a supplemental report.Remains implanted.

Event Description

In (b)(6) 2015 i had the implant due to trigger finger, hypertension and swan neck that was locking and very painful.My surgeon at (b)(6) hospital convinced me that the sr pip implant was a device that would solve all of my finger/joint problems.Little did i know it was the beginning of a very long road including 3 other surgeries to correct the previous implants.Then in (b)(6) 2015 i had a second surgery to break the adhesions and to check the device.Revision #1 (b)(4).Because it was hyper extend at the pip implant i had a third surgery in (b)(6) 2016 to correct/repair the volar pate tendon.After months of therapy and devices the joint still hyper extend and was very painful.Revision #2 (b)(4).I decided to seek another surgeon at (b)(6).He came highly recommended.He informed me that the pip implant was crooked and loose.His suggestion was to do a sorl procedure.Again, after months of pt it sill was crooked, sore at the proximal phalange and continued to hyperextend.I am on my third surgeon who informed me that pip implants do not have a high rate of success, which i was never told.I was informed that my only option was to have it fused, to eliminate the pain but that success rate of fusion is under 50% because the phalanges had to be cut for the implant which makes it difficult for the bones to fuse.As you can tell i tried all options and surgeries and that sr pip implant is a failure.I remember i had to sign a paper to have that implant because it as not approved by the fda because not many surgeries were done with that device.I hope that since you purchased the company improvements have been made with that device.I have to live in constant pain due to a device that was flawed or a device that was not implanted correctly.

Manufacturer Narrative

Update conclusion on (b)(6)2019, based on new information and documents provided: the reported event that proximal interphalangeal implant, size 4 was alleged of 'patient pain' could be confirmed.Based on investigation, the root cause was attributed to be user related.A medical opinion was requested to our medical consultant.His assessment says: "it is not easy- if not impossible- to judge this case without knowing the results of the first preoperative examinations and the first x-rays.From the complaint email you send me and from which your email is citing we learn, that the patient was suffering pain, hypertension (the patient probably wanted to say: hyperextension) and swan neck deformity.Following the patients letter it was also severe arthritic.Following the letter of dr.C.There was a pre-existing swan-neck-deformity after pip-arthroplasty.No sufficient information is given on the indication that led to the arthroplasty.In this situation, we have to guess the reasons why the surgeon decided to replace the joint.The main problem from my point of view is that we are not provided with any information on the reason for the swan neck deformity.The reason for the deformity is the key information we need to assess whether a joint replacement can be justified or not.There are several clinical conditions that can lead to swan neck deformity; most common is: -volar plate laxity at pipj -spasticity due to stroke or cerebral palsy -rheumatoid arthritis -posttraumatic after fractures of the p2 -mallet deformity of dipj, with laxity of the volar plate at the pipj.As can be seen in the list arthritis or arthrosis of the joint ending up with swan neck deformity seems to be very rare.The bouchard arthrosis of the pip usually ends up with lateral deformity or deviation of the p2 and p3.One has the feeling that either the diagnosis, respectively the underlying cause of the disease was not assessed properly-but this- as mentioned before- cannot be said for sure.Joint replacement is definitely not the first surgical option to choose when a swan neck deformity occurs.If there was a severe destruction of the joint the surgeon should know that the result of the procedure is clearly depending on the ligament stability provided with the pip-joint.From the literature it can be seen that the results are highly dependant on this stability.Tthe replacement of the pip has in comparison to other joints high complication rates and they are even higher if stability is not provided.It seems clear that under these circumstances additionally to the joint replacement further surgical procedures to restore the stability of the joint and to restore the neutral extension condition in the pip have to be performed.The patients statement ¿the only options i had was (1) live with it or (2) have a pip implant.¿ is at least a little bit surprising, because arthrodesis of the joint would have been another option-maybe with much less complications.However, from the further history we see that two-more or less expectable- complications occurred: the loosening of the implant and the reoccurrence of the swan neck deformity.The (third?) operation described by dr.C.Addressed mainly the problem of the deformity.And if we look at the sorl-procedure it is unclear-at least to me-whether this can be performed with having a chance of success when a joint replacement is present like in this case.It seems that unfortunately we can only learn that the careful and responsible examination and anamnesis of the patient is essential in hand surgery and that hhis basic rule has not been complied with in the present case.With further information (clinical situation/x-ray preoperatively) i could probably assess this case better, but in the end the wrong indication for the replacement seems to be the problem here." [original statement] a review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If the device is returned or if any additional information is provided, the investigation will be reassessed.

Event Description

In march 2015 i had the implant due to trigger finger, hypertension and swan neck that was locking and very painful.My surgeon at the hershey medical hospital convinced me that the sr pip implant was a device that would solve all of my finger/joint problems.Little did i know it was the beginning of a very long road including 3 other surgeries to correct the previous implants.Then in august 2015 i had a second surgery to break the adhesions and to check the device.Revision #1 pi 1934692 because it was hyper extend at the pip implant i had a third surgery in june 2016 to correct/repair the volar pate tendon.After months of therapy and devices the joint still hyper extend and was very painful.Revision #2 pi 1940372 i decided to seek another surgeon at the philadelphia hand institute.He came highly recommended.He informed me that the pip implant was crooked and loose.His suggestion was to do a sorl procedure.Again, after months of pt it sill was crooked, sore at the proximal phalange and continued to hyperextend.I am on my third surgeon who informed me that pip implants do not have a high rate of success, which i was never told.I was informed that my only option was to have it fused, to eliminate the pain but that success rate of fusion is under 50% because the phalanges had to be cut for the implant which makes it difficult for the bones to fuse.As you can tell i tried all options and surgeries and that sr pip implant is a failure.I remember i had to sign a paper to have that implant because it as not approved by the fda because not many surgeries were done with that device.I hope that since you purchased the company improvements have been made with that device.I have to live in constant pain due to a device that was flawed or a device that was not implanted correctly.

• Brand Name: PROXIMAL INTERPHALANGEAL IMPLANT, SIZE 4
• Type of Device: SEMI-CONSTRAINED METAL/POLYMER FINGER JOINT PROSTHESIS
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 8122212
• MDR Text Key: 129028398
• Report Number: 0008031020-2018-01019
• Device Sequence Number: 1
• Product Code: MPK
• Combination Product (y/n): N
• PMA/PMN Number: H980002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 02/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/30/2018
• Device Catalogue Number: SRPIP4
• Device Lot Number: 23481502
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other