FDA Adverse Event
Injury
Summary report: N
ARCOS HA MODULAR REVISION SYSTEM CONE PROXIMAL BODY 60MM
MDR report key: 6153080
·
Received December 7, 2016
Report
- Report Number
- 0001825034-2016-05077
- Event Type
- Injury
- Date Received
- December 7, 2016
- Date of Event
- April 25, 2015
- Report Date
- July 28, 2017
- Manufacturer
- BIOMET ORTHOPEDICS
- Product Code
- KWA
- PMA / PMN Number
- PEXEMPT
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SW
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THIS PRODUCT IS NOT CLEARED FOR DISTRIBUTION IN THE U.S. HOWEVER, THIS REPORT IS BEING SUBMITTED AS A SIMILAR DEVICE IS CLEARED UNDER 510K NUMBER K090757. THIS REPORT IS NUMBER 1 OF 2 MDR'S FILED FOR THE SAME PATIENT (REFERENCE 1825034-2016-05077 / 00???).
Additional Manufacturer Narrative · 1
UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED THIS REPORT IS A DUPLICATE OF MFR NUMBER 0001825034-2017-01432. THIS REPORT SHOULD BE VOIDED.
Description of Event or Problem · 1
IT WAS REPORTED PATIENT UNDERWENT LEFT HIP ARTHROPLASTY . SUBSEQUENTLY PATIENT EXPERIENCED FEMORAL PAIN 6 MONTHS POST-OPERATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 802951 | ARCOS HA MODULAR REVISION SYSTEM CONE PROXIMAL BODY 60MM | PROSTHESIS, HIP | KWA | BIOMET ORTHOPEDICS | N/A | 214750 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR | Required Intervention |