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| Catalog Number UNK - IMPLANT |
| Device Problem
Migration or Expulsion of Device (1395)
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| Patient Problems
Unspecified Infection (1930); No Code Available (3191)
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Event Type
Injury
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Manufacturer Narrative
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Product complaint #: (b)(4).(b)(4).Udi: the udi and lot number are unknown.
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Event Description
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This report is being filed after the review of the following journal article: arsi, h., et al (2009) a prospective comparison of 3 hamstring acl fixation devices¿rigidfix, bioscrew, and intrafix¿randomized into 4 groups with 2 years of follow-up.The american journal of sports medicine, vol.37 (4), pages 699-706.(finland) the study emphasizes on the hypothesis on having similar clinical outcome after either cross-pin or absorbable interference screw fixation in anterior cruciate ligament reconstruction with hamstring tendons.The patients evaluated on course of this study: a total of 120 patients were randomized into 4 different groups (30 each) for anterior cruciate ligament reconstruction with hamstring tendons: femoral rigidfix cross-pin and intrafix tibial expansion sheath with a tapered expansion screw; rigidfix femoral and bioscrew interference screw tibial fixation, bioscrew femoral and intrafix tibial fixation; or bioscrew fixation into both tunnels.The evaluation methods were clinical examination, knee scores, and instrumented laxity measurements.The article describes the following procedure: the graft in rigidfix fixation was constructed according to the manufacturer¿s instructions with whipstitches of no.1 vicryl (ethicon inc, johnson & johnson, somerville, new jersey) to join the doubled limbs of the semitendinosus and gracilis tendons together.With the rigidfix instrumentation, 2 transverse drill tunnels were drilled to receive the fixation devices.After the graft was passed into the drill tunnel by pulling it with no.2 vicryl loop left in the graft end, 2 rigidfix implants were tapped through the drill guide sleeves transfixing the graft and advanced to the bone medial to the drill tunnel.The devices involved were: intrafix (depuy mitek, raynham, massachusetts).Rigidfix crosspin (depuy mitek).Complications and additional procedures: there was one perioperative technical complication when posterior blowout of the femoral graft tunnel occurred in a rigidfix/intrafix case and the graft was secured with staple fixation.A broken screw guide wire was noted in the postoperative radiograph, and it was removed arthroscopically the next day (bioscrew/intrafix group).In one case (bioscrew/bioscrew group) a hematoma in the harvest site was evacuated the first postoperative day.These complications did not affect the outcome.Two infections were noted, of which one was a deep infection requiring washout arthroscopies and antibiotic treatment with eventual healing and a stable knee (bioscrew/bioscrew group).The other one was an infection at the tibial entry site in a patient belonging to the bioscrew/intrafix group.After operative debridement and eventual healing, the knee became slightly unstable with 1+ lachman, negative pivot-shift, and 6 mm side-to-side difference in kt-2000 arthrometer manual maximum laxity tests.In one case, a deep-vein thrombosis was diagnosed with uneventful recovery after thrombolytic treatment (bioscrew/ intrafix group).In addition to the 3 revision acl reconstructions, there was surgery in 7 cases during the 2-year follow-up period.One intrafix device was removed (extrusion) and in another case a broken bioscrew tip was removed from the knee joint.
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Manufacturer Narrative
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This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H10 additional narrative: investigation summary: the complaint device is not being returned, it was implanted in the patient, therefore unavailable for a physical evaluation.This complaint file was opened to document complaints derived through a journal article review.The journal article review indicated depuy mitek product failure(s).Multiple attempts were done to obtain more information from the author, however, no response was received.It is unknown if complaints derived from this journal article were previously reported and documented in the depuy mitek complaint system at the time of occurrence as no product code/lot number information was provided to perform the search.With the information provided, and without the complaint device to evaluate, we cannot determine a root cause for the reported problem.Since no lot number was provided, a manufacturing record evaluation or sterile load review could not be conducted.If any additional information is obtained, this complaint will be re-opened to capture that information.At this point in time, no corrective action is required, and no further action is warranted.However, depuy synthes mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.
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Search Alerts/Recalls
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