MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,health professional, report with the FDA on 2020-01-31 for 40MM OXINIUM MODULAR HEAD 71342340 manufactured by Smith & Nephew, Inc..
[177171071]
It was reported that a revision surgery was performed due to infection. The hip was dislocated and the oxinium head was removed. The acetabulum was exposed and the liner was removed. Following this, the hip was irrigated with a zimmer antibiofilm solution for 1 liter followed by 3 liters of bacitracin in saline. All devitalized tissue and exudate were all debrided. A new liner was placed in the same position as the previous liner with anterior hood and same size head and neck, 40 mm was applied. The hip was reduced and stable with a full range of motion. Antibiotic dusting with vancomycin and tobramycin was carried out and then the surgical intervals were reapproximated with monofilament suture over 4 hemovac drains. An incisional wound vac was applied. Eight days after the revision surgery the patient developed an hematoma and it was surgically evacuated.
Patient Sequence No: 1, Text Type: D, B5
[188440671]
The devices, used in treatment were not returned for evaluation, reporting event could not be confirmed. A clinical evaluation was conducted and confirms the origin of the infection is highly likely of an exogenous nature and there is no evidence that our product contributed to the infection. The patient? S history of coagulopathy cannot be ruled out as a contributing factor to her hematoma formation. In addition, the root cause of the hematoma cannot be concluded; it is a known complication of joint surgeries and is related to the procedure and not the device. The patient impact beyond the infection, hematoma, revision and expected transient post op convalescence period cannot be determined. A review of complaint history on the listed part revealed no prior complaints for the listed batch with the same failure mode. A review of the device history records for the listed batch did not reveal any deviation from the standard manufacturing processes. This included a review of sterilization documents which indicated that the product was sterilized according to sterilization release documentation. Infection, a potential complication associated with any surgery, can occur and possible causes could include but not limited to contamination, patient reaction, and post-operative healing issue. At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture. Based on this investigation, the need for corrective action is not indicated. Without the actual product involved and/or device information, our investigation cannot proceed. If the device or new information is received in the future, this complaint can be re-opened. No further actions are being taken at this time. We consider this investigation closed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1020279-2020-00424 |
| MDR Report Key | 9652937 |
| Report Source | CONSUMER,HEALTH PROFESSIONAL, |
| Date Received | 2020-01-31 |
| Date of Report | 2020-01-31 |
| Date of Event | 2017-06-14 |
| Date Mfgr Received | 2020-01-14 |
| Device Manufacturer Date | 2017-02-15 |
| Date Added to Maude | 2020-01-31 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | DR SARAH FREESTONE |
| Manufacturer Street | 1450 BROOKS ROAD |
| Manufacturer City | MEMPHIS TN 38116 |
| Manufacturer Country | US |
| Manufacturer Postal | 38116 |
| Manufacturer Phone | 0447940038 |
| Manufacturer G1 | SMITH & NEPHEW, INC. |
| Manufacturer Street | 1450 BROOKS ROAD |
| Manufacturer City | MEMPHIS TN 38116 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 38116 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 40MM OXINIUM MODULAR HEAD |
| Generic Name | PROSTHESIS, HIP, SEMI-CONS, UNCEMENTED, METAL/POLYMER, POROUS |
| Product Code | MBL |
| Date Received | 2020-01-31 |
| Catalog Number | 71342340 |
| Lot Number | 17BM11390 |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITH & NEPHEW, INC. |
| Manufacturer Address | 1450 BROOKS ROAD MEMPHIS TN 38116 US 38116 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2020-01-31 |