MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-27 for STRYKER PIP #2, #3 manufactured by Stryker Gmbh.
[140312117]
Doctor (b)(6) of (b)(6) recommended stryker pip implants for my left index proximal, left index distal and left long finger. Implants put in on (b)(6) 2016 immediate swan neck deformity on middle finger and long finger. Finger next to thumb implant has loosened. Middle finger came out of joint (dislocated). 3 times. Finger next to pinky. Severe swan neck syndrome. Other joint loose in place. Remedial surgery on (b)(6) 2018 to shorted tendons to prevent dislocations and swan neck. Must wear brace 24/7 on middle finger. Much pain/discomfort/nerve damage. Immediately post operative exam showed swan neck. Deformity on middle and ring finger as well as numbness in ring finger. Pain has been constant, as has stiffness. Post operative concerns voiced to (b)(6) to no avail. Eventually, pain increased, joint would dislocate. Finger next to thumb swollen, joint (stryker) loose. Xrays show significant bone loss due to implant being harder than bone and bone being destroyed at all implant locations. Bone at all implant sites is deteriorating.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5085250 |
| MDR Report Key | 8459729 |
| Date Received | 2019-03-27 |
| Date of Event | 2016-01-21 |
| Date Added to Maude | 2019-03-28 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | STRYKER PIP #2, #3 |
| Generic Name | SEMI-CONSTRAINED METAL/POLYMER FINGER JOINT PROSTHESIS |
| Product Code | MPK |
| Date Received | 2019-03-27 |
| Model Number | PIP |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER GMBH |
| Brand Name | STRYKER PIP #2, #3 |
| Generic Name | SEMI-CONSTRAINED METAL/POLYMER FINGER JOINT PROSTHESIS |
| Product Code | MPK |
| Date Received | 2019-03-27 |
| Model Number | PIP |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | STRYKER GMBH |
| Brand Name | STRYKER PIP #2, #3 |
| Generic Name | SEMI-CONSTRAINED METAL/POLYMER FINGER JOINT PROSTHESIS |
| Product Code | MPK |
| Date Received | 2019-03-27 |
| Model Number | PIP |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 3 |
| Device Event Key | 0 |
| Manufacturer | STRYKER GMBH |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2019-03-27 |