MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2019-04-30 for ALTIVATE SHOULDER 520-40-214 manufactured by Encore Medical L.p..
[143616442]
The reason for this revision surgery was reported as an infection. The previous surgery and the revision detailed in this investigation occurred 14 days apart. No information was submitted with the complaint regarding pre-existing conditions of the patient or any activities the patient was involved in that may have contributed to the infection or inhibited the patient's immune system. 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 (dhrs) show that the reported component used in the previous surgery met design and manufacturing requirements. There were no non-conforming material reports (ncmrs) associated with the product that may have contributed to an infection. Customer complaint history of the reported device showed no present trends or on-going issues that are in need of review. 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. There were no findings during this investigation that indicate that the reported device was the root cause or had a direct connection with the patient's infection. Due to the short time between the original surgery and the revision, it is possible that the infection was acquired in the hospital (nosocomial). It is also possible that the patient was not compliant with post surgical instructions. There are multiple factors that may contribute to an infection that are outside of the control of djo surgical. There are no indications of a product or process issue affecting implant safety or effectiveness.
Patient Sequence No: 1, Text Type: N, H10
[143616443]
Revision surgery - due to a possible infection.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1644408-2019-00352 |
| MDR Report Key | 8566695 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2019-04-30 |
| Date of Report | 2019-04-30 |
| Date of Event | 2019-04-03 |
| Date Mfgr Received | 2019-04-03 |
| Device Manufacturer Date | 2017-07-17 |
| Date Added to Maude | 2019-04-30 |
| 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 787585445 |
| Manufacturer Country | US |
| Manufacturer Postal | 787585445 |
| Manufacturer G1 | ENCORE MEDICAL L.P. |
| Manufacturer Street | 9800 METRIC BLVD |
| Manufacturer City | AUSTIN TX 787585445 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 787585445 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ALTIVATE SHOULDER |
| Generic Name | ALTIVATE ANATOMIC, NEUTRAL HUMERAL HEAD, 40X14 |
| Product Code | PAO |
| Date Received | 2019-04-30 |
| Model Number | 520-40-214 |
| Catalog Number | 520-40-214 |
| Lot Number | 862U1013 |
| 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 787585445 US 787585445 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 520 | 1. Required No Informationntervention | 2019-04-30 |