MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-01 for TURON SHOULDER 521-01-250 manufactured by Encore Medical, L.p..
[140586114]
The reason for this revision surgery was due to inflammation and torn rotator cuff. The previous surgery and the surgery detailed in this investigation occurred 2. 2 years apart. 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. There are no reported pre-existing patient health conditions. The healthcare professional indicated 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 djo surgical for examination. A review of the implant device history records (dhr), shows that the reported component used in the previous surgery, when released for use, met design and manufacturing requirements. There were no non-conforming material reports (ncmrs) associated with the product that may have contributed to the reported event. The device was verified to have gone through an acceptable sterilization process and was within its expiration date at the time of use during the previous surgery. Customer complaint history of the reported device showed no present trends or on-going issues that are in need of review. The root cause of this complaint was a revision surgery due to inflammation and torn rotator cuff. There were no findings during this investigation that indicate that the reported device was defective. There are multiple factors that may contribute to an event that are outside of the control of djo surgical. 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
[140586115]
Revision surgery - due to inflammation and extra fluid in the shoulder; torn rotator cuff.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1644408-2019-00248 |
| MDR Report Key | 8471508 |
| Date Received | 2019-04-01 |
| Date of Report | 2019-04-01 |
| Date of Event | 2019-03-04 |
| Date Mfgr Received | 2019-03-04 |
| Device Manufacturer Date | 2013-10-25 |
| Date Added to Maude | 2019-04-01 |
| 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 | TEFFANY HUTTO |
| Manufacturer Street | 9800 METRIC BLVD. |
| Manufacturer City | AUSTIN TX 787586313 |
| Manufacturer Country | US |
| Manufacturer Postal | 787586313 |
| Manufacturer G1 | ENCORE MEDICAL, L.P. |
| Manufacturer Street | 9800 METRIC BLVD. |
| Manufacturer City | AUSTIN TX 787586313 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 787586313 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | TURON SHOULDER |
| Generic Name | TURON PEGGED GLENOID, SZ 50MM, EPLUS |
| Product Code | PAO |
| Date Received | 2019-04-01 |
| Model Number | 521-01-250 |
| Catalog Number | 521-01-250 |
| Lot Number | 801N1006 |
| Device Expiration Date | 2018-10-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 787586313 US 787586313 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-04-01 |