MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2016-06-29 for LESSER METATARSAL PHALANGEAL JOINT IMPLANT manufactured by Tornier Inc..
[48468105]
Patient Sequence No: 1, Text Type: N, H10
[48468106]
According to information received: "there is an allegation that ms. (b)(6) was injured by a left foot implant on (b)(6) 2014. Ms. (b)(6) was allegedly treated beginning in (b)(6) 2013 for pain and tenderness along the second mpj of her left foot. In (b)(6) 2014, she underwent surgery for the placement of a tornier, inc. Implant on the second mpj of her left foot. Postoperatively, however, she continued to complaint about diffuse pain around the second mpj on the left foot. In (b)(6) 2014, she underwent an mri which reportedly showed bone marrow edema surrounding the prosthesis but no fracture or bone erosion at the site, and it was suspected by her physicians that she had developed a stress injury. Ultimately, a neuroma was removed from her left foot on (b)(6) 2014. On (b)(6) 2014, ms. (b)(6) was admitted for a planned transforaminal epidural steroid injection procedure at fullerton surgical center. The purpose of the injection was to relieve pain in her lower back related to a prior car accident. At the time of the injection, she was wearing an orthopedic boot on her lower left leg as a result of the previous left foot implant surgery, and subsequent surgery to remove the neuroma. Allegedly, she awoke from the injection on (b)(6) 2014 with a headache and significant pain in her surgically repaired left foot. She alleged that the treating doctors damaged her surgically repaired foot while she was under anesthesia. On (b)(6) 2014, she was found to have refractured her left foot, causing hardware loosening of the implant. An expert provided by the surgery center allegedly opined that to a reasonable degree of medical certainty, the foot problems she experienced after injection surgery were not caused by the medical facility. Although it appears that the implant allegedly did become damaged sometime in (b)(6) 2014, there is no evidence per the expert that it was damaged during the (b)(6) procedure. The expert allegedly stated that there were a myriad of ways the implant could have been damaged following is implantation, and that the type of implant she received is "fragile" and "can rupture very easily. " he allegedly stated that the implant could have been damaged by normal wear and tear, or by her catching her toe or tripping at any time after it was placed. The location of the product at issue is not known. From reviewing some of the recently available (but limited) records in the companion state court medical malpractice case that it appears plaintiff did have the tornier implant removed on (b)(6) 2014, but the surgeon gave the implant to the plaintiff and she has retained it ever since. There is no indication in those records it was ever sent back to tornier for review and inspection. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004983210-2016-00021 |
| MDR Report Key | 5759571 |
| Report Source | CONSUMER |
| Date Received | 2016-06-29 |
| Date of Report | 2016-04-06 |
| Date of Event | 2015-06-04 |
| Date Mfgr Received | 2016-04-06 |
| Date Added to Maude | 2016-06-29 |
| 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 |
| Reporter Occupation | ATTORNEY |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. DUSTIN SMITH |
| Manufacturer Street | 10801 NESBIT AVE SOUTH |
| Manufacturer City | BLOOMINGTON MN 55437 |
| Manufacturer Country | US |
| Manufacturer Postal | 55437 |
| Manufacturer Phone | 9529217121 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LESSER METATARSAL PHALANGEAL JOINT IMPLANT |
| Generic Name | PROSTHESIS, TOE, CONSTRAINED, POLYMER |
| Product Code | KWH |
| Date Received | 2016-06-29 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TORNIER INC. |
| Manufacturer Address | 10801 NESBIT AVENUE SOUTH BLOOMINGTON MN 55437 US 55437 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-06-29 |