MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-12-01 for PROXIMAL INTERPHALANGEAL IMPLANT, SIZE 4 SRPIP4 manufactured by Stryker Gmbh.
[129028398]
Device will not be returned. If additional information becomes available it will be provided on a supplemental report. Remains implanted.
Patient Sequence No: 1, Text Type: N, H10
[129028399]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0008031020-2018-01019 |
| MDR Report Key | 8122212 |
| Date Received | 2018-12-01 |
| Date of Report | 2019-02-22 |
| Date of Event | 2015-08-01 |
| Date Mfgr Received | 2019-02-07 |
| Device Manufacturer Date | 2013-08-13 |
| Date Added to Maude | 2018-12-01 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. ANNA JUSINSKI |
| Manufacturer Street | 325 CORPORATE DRIVE |
| Manufacturer City | MAHWAH NJ 07430 |
| Manufacturer Country | US |
| Manufacturer Postal | 07430 |
| Manufacturer Phone | 2018315000 |
| Manufacturer G1 | STRYKER GMBH |
| Manufacturer Street | BOHNACKERWEG 1 POSTFACH |
| Manufacturer City | SELZACH 2545 |
| Manufacturer Country | CH |
| Manufacturer Postal Code | 2545 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | PROXIMAL INTERPHALANGEAL IMPLANT, SIZE 4 |
| Generic Name | SEMI-CONSTRAINED METAL/POLYMER FINGER JOINT PROSTHESIS |
| Product Code | MPK |
| Date Received | 2018-12-01 |
| Catalog Number | SRPIP4 |
| Lot Number | 23481502 |
| Device Expiration Date | 2018-06-30 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER GMBH |
| Manufacturer Address | BOHNACKERWEG 1 POSTFACH SELZACH 2545 CH 2545 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-12-01 |