MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2016-03-29 for FMP HIP 931-44-760 manufactured by Encore Medical, L.p..
[41366235]
Revision surgery - due to the patient dislocating.
Patient Sequence No: 1, Text Type: D, B5
[47921558]
The reason for this revision surgery was hip dislocation. The length of the in-vivo service was 2. 4 months. There is no information in this complaint about any patient injuries, activities, or accidents that may have contributed to the need for this revision surgery. The healthcare professional indicated there was a serious risk to the patient. There was no delay in surgery and another suitable device was available for use. The revision surgery was completed as intended. The device was disposed of at the hospital and not made available to (b)(4) for examination. A review of the device history records (dhrs) revealed no discrepancies or issues with the manufacturing history of this part. All parts were found to meet design and manufacturing specifications. No non-conforming material reports (ncmr's) were associated with this part. The product complaint report history was reviewed and no trends or on-going issues were deemed as present or in need of review. This event is deemed to be non-product related. The surgeon reported no issues associated with the explanted product and provided no information that definitively described the root cause or reason of the dislocation. The scope of this investigation is limited without having the parts available to (b)(4)for evaluation. Other conditions relating to this event could not be determined with confidence. Factors that may contribute to a dislocation not associated with the implant are: improper implant selection, degenerative bone disease, and improper surgical technique. Inventory containment is not required as there are no indications of a product or process issue affecting implant safety or effectiveness.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1644408-2016-00219 |
| MDR Report Key | 5531713 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2016-03-29 |
| Date of Report | 2016-03-04 |
| Date of Event | 2016-03-04 |
| Date Mfgr Received | 2016-06-13 |
| Device Manufacturer Date | 2014-01-23 |
| Date Added to Maude | 2016-03-29 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. TEFFANY HUTTO |
| Manufacturer Street | 9800 METRIC BLVD. |
| Manufacturer City | AUSTIN TX 787585445 |
| Manufacturer Country | US |
| Manufacturer Postal | 787585445 |
| Manufacturer Phone | 5128346255 |
| Manufacturer G1 | ENCORE MEDICAL, L.P. |
| Manufacturer Street | 9800 METRIC BLVD. |
| Manufacturer City | AUSTIN TX 78758 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 78758 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FMP HIP |
| Generic Name | LINER/NON-HOODED-NEU, MP10, HXE-PLUS, 44MM |
| Product Code | OQH |
| Date Received | 2016-03-29 |
| Catalog Number | 931-44-760 |
| Lot Number | 764N1002 |
| Device Expiration Date | 2019-01-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ENCORE MEDICAL, L.P. |
| Manufacturer Address | 9800 METRIC BLVD. AUSTIN TX 78758 US 78758 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2016-03-29 |