MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-04-22 for NEXGEN COMPLETE KNEE SOLUTION POLY PATELLA 5972-65-32 manufactured by Zimmer.
[16852898]
I have had gentamicin-induced vestibulopathy - bilateral vestibular hypofunction - moderate to severe since 1991 documented in my 1993 us (b)(6)medical board. This allergy/sensitivity/toxicity was known by dr. (b)(6), (b)(4) med ctr, (b)(6), as part of the (b)(6) program. Some 1000mg of gentamycin was put in the bone cement implant of a r total knee arthroplasty plus 2000mg iv of vancomycin. Both ototoxic. I was told by dr. (b)(6) that he would "substitute keflex" which he did not do. I have become increasingly symptomatic since and now have "severe bilateral vestibular hypofunction" and a high frequency hearing loss. At present, the (b)(6) is trying to determine whether or not the implants should be removed and revised. Would there be less damage with a one-time bolus of gentamicin when the implants are removed vs. Slow elution of tiny amounts of gentamycin released on a daily basis. What studies do the fda have to answer this question? Please advise. Dr. (b)(6), (b)(6) med ctr performed a tka (replacement) of r knee ignoring my history of gentamicin toxicity which was told to him prior to surgery. Told he would "substitute keflex" in the bone cement mix. Did not do so. Implants continue to elute (leach) small amounts of gentamycin for up to 25 years. Staff failed to adhere to contraindications of use of gentamycin given previous history of known allergy/sensitivity/toxicity.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5042278 |
| MDR Report Key | 4729800 |
| Date Received | 2015-04-22 |
| Date of Report | 2015-04-15 |
| Date of Event | 2013-07-08 |
| Date Added to Maude | 2015-04-28 |
| 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 | 0 |
| Reporter Occupation | PATIENT |
| Health Professional | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NEXGEN COMPLETE KNEE SOLUTION POLY PATELLA |
| Generic Name | KNEE REPLACEMENT |
| Product Code | HTG |
| Date Received | 2015-04-22 |
| Catalog Number | 5972-65-32 |
| Lot Number | 62394734 |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZIMMER |
| Brand Name | TIBIAL TRAY |
| Generic Name | TIBIAL |
| Product Code | HSH |
| Date Received | 2015-04-22 |
| Catalog Number | 00-5954-037-02 |
| Lot Number | 621066003 |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | ZIMMER |
| Brand Name | CRUCIATE RETRAINING FEMORAL COMPONENT |
| Generic Name | FEMORAL COMPONENT |
| Product Code | JWH |
| Date Received | 2015-04-22 |
| Catalog Number | 5952-15-06 |
| Lot Number | 62318594 |
| Device Sequence No | 3 |
| Device Event Key | 0 |
| Manufacturer | ZIMMER |
| Brand Name | ARTICULAR SURFACE |
| Generic Name | ARTICULAR SURFACE |
| Product Code | JWH |
| Date Received | 2015-04-22 |
| Catalog Number | 5952-30-10 |
| Lot Number | 62280599 |
| Device Expiration Date | 2018-07-01 |
| Device Sequence No | 4 |
| Device Event Key | 0 |
| Manufacturer | ZIMMER |
| Brand Name | CANCELLOUS SCREWS |
| Generic Name | SCREW |
| Product Code | HWC |
| Date Received | 2015-04-22 |
| Catalog Number | UNK |
| Lot Number | UNK |
| Device Sequence No | 5 |
| Device Event Key | 0 |
| Manufacturer | ZIMMER |
| Brand Name | BONE CEMENT WITH GENTAMICN |
| Generic Name | BONE CEMENT |
| Product Code | LOD |
| Date Received | 2015-04-22 |
| Catalog Number | 00-1113-140-01 |
| Lot Number | 75434316 |
| Device Expiration Date | 2016-07-01 |
| Device Sequence No | 6 |
| Device Event Key | 0 |
| Manufacturer | ZIMMER |
| Brand Name | BONE CEMENT WITH GENTAMICIN |
| Generic Name | BONE CEMENT |
| Product Code | LOD |
| Date Received | 2015-04-22 |
| Catalog Number | 00-1113-140-01 |
| Lot Number | 76414339 |
| Device Expiration Date | 2017-01-01 |
| Device Sequence No | 7 |
| Device Event Key | 0 |
| Manufacturer | ZIMMER |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2015-04-22 |