MAUDE Adverse Event Report: OSTEOMED, LLC; PROSTHESIS, TOE (METATARSOPHALANGEAL), JOINT, METAL/POLYMER, SEMI-CONSTRAINED

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pain (1994)

Event Type  Injury  

Manufacturer Narrative

The complaint was documented as a result of review of scientific literature article due to the adverse events reported.No product malfunction or failure was reported in the literature.Device information (model number and batch/lot number) is unknown.Therefore, device history review (dhr) review could not be performed.The device was not received for evaluation.Additionally, as the device information is unknown, a review of the complaint database could not be performed based on part number; however, a review was still performed based on the reported event with no additional complaints were noted.The ifu for the bio-action great toe implant was reviewed, and based on this review, potential causes for these reported complications include excessive functional stress on the implant, incorrect type and size selection of the implant, and patient noncompliance with post-op instructions.However, based on the information received and the investigation performed, the root cause could not be conclusively determined.Related reports: 2027754-2023-00055, 2027754-2023-00056, and 2027754-2023-00058.

Event Description

In the article "first metatarsophalangeal joint replacement using the bio-action great toe implant: intermediate results" by pulavarti, r.S, et al, the authors performed a prospective study to evaluate total joint replacement of the hallux mtp joint using a two-piece, nonconstrained total joint replacement system (bio-action great toe implant manufactured by osteomed).Between august, 1998, and may, 2004, 53 total joint replacements were done in 48 patients.Those patients with severe degenerative changes in the first mtp joint who were otherwise candidates for either resection arthroplasty or arthrodesis were included in the study.The main indications included symptomatic hallux rigidus (hattrup and johnson grade iii) refractory to conservative measures, symptomatic degeneration secondary to a long-standing hallux valgus, previous failed hallux surgery with painful degeneration and restriction of function and motion, and symptomatic degeneration of the first mtp joint after trauma or inflammatory or metabolic disorders.The authors reviewed the results of 32 patients (36 replacements including four bilateral) with a minimum followup of 36 months.Since the aim of this study was to evaluate the intermediate results, only patients with at least 36 months of followup were included in the analysis.The mean age was 57 (38 to 72) years and mean followup was 47 (36 to 69) months.There were 24 females and eight males.Those patients who opted to have the total joint replacement using the bio-action great toe implant and were willing to participate in the study were informed about the limitations and possible complications of the procedure.All the patients who agreed to participate in the study were carefully assessed preoperatively and at regular intervals postoperatively.The principal symptoms, disabilities, range of movement, footwear problems, and any associated deformities were assessed preoperatively and postoperatively at each followup visit.Subjective assessment was done by using grades of satisfaction as excellent, good, fair, or poor.Assessment also was done by using the hallux mtp scale.Patients were evaluated at 2 weeks, 6 weeks, 3 months, 12 months, and annually thereafter unless otherwise indicated.The following post-operative complications were reported: ·three patients who continued to have pain after the operation rated the result as poor.Two of the three patients who had poor outcome had revision surgery which included: a) one patient had removal of the implant and excision arthroplasty, and b) the other patient had arthrodesis of the joint 30 months after the primary replacement.There was no obvious cause to explain the poor results in all the three cases.The following intraoperative complications were reported: ·one intraoperative complication of fracture of the first metatarsal while inserting the implant.This was treated by cerclage wiring.Report 3 of 4 for this event.

• Type of Device: PROSTHESIS, TOE (METATARSOPHALANGEAL), JOINT, METAL/POLYMER, SEMI-CONSTRAINED
• Manufacturer (Section D): OSTEOMED, LLC; 3885 arapaho rd; addison TX 75001
• Manufacturer (Section G): OSTEOMED, LLC; 3885 arapaho rd; addison TX 75001
• Manufacturer Contact: ellie wood ; 3885 arapaho rd; addison, TX 75001 ; 9726774600
• MDR Report Key: 18242901
• MDR Text Key: 329433993
• Report Number: 2027754-2023-00057
• Device Sequence Number: 1
• Product Code: LZJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K922211
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Literature
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other