MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-12-01 for UNKNOWN SR PIP UNK_SEL manufactured by Stryker Gmbh.
[129039415]
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
[129039416]
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 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 (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 pi (b)(4). 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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0008031020-2018-01020 |
| MDR Report Key | 8122228 |
| Date Received | 2018-12-01 |
| Date of Report | 2019-01-17 |
| Date of Event | 2015-08-01 |
| Date Mfgr Received | 2018-12-20 |
| 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. ROSE HAAS |
| 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 | UNKNOWN SR PIP |
| Generic Name | IMPLANT |
| Product Code | MPK |
| Date Received | 2018-12-01 |
| Catalog Number | UNK_SEL |
| Lot Number | UNKNOWN |
| 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 |