FDA Adverse Event
Injury
Summary report: N
SPIDERCUP
MDR report key: 8211830
·
Received January 3, 2019
Report
- Report Number
- 0009610576-2019-00002
- Event Type
- Injury
- Date Received
- January 3, 2019
- Report Date
- January 3, 2019
- Manufacturer
- BIOMET SPAIN, S.L.
- Product Code
- PBI
- PMA / PMN Number
- SEE H10
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THIS DEVICE IS NOT MANUFACTURED BY ZIMMER BIOMET IN UNITED STATES, HOWEVER, WE ARE FILING THIS REPORT AS ZIMMER BIOMET MANUFACTURES A SIMILAR DEVICE IN THE UNITES STATES UNDER 510K NUMBER K030055. PRODUCT NOT RETURNED.
Description of Event or Problem · 1
AS A PART OF POST MARKET SUVEILLANCE (PMS) OF SPIDERCUP CUP, THE PMS TEAM HAS REVIEWED THE SURVEY COMPLETED BY DR (B)(6) OF THE HOSPITAL (B)(6). DURING THE REVIEW, SEVERAL EVENTS WERE DETECTED ABOUT THE INCIDENTS THAT ARE MENTIONED: POST-OPERATIVE COMPLICATIONS (DEEP INFECTION LESS 3 MONTHS, DISLOCATION) IMPLANT REVISION (CAUSED BY CERAMIC OR POLYETHYLENE WEAR).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 4366 | SPIDERCUP | PROTHESIS, HIP | PBI | BIOMET SPAIN, S.L. | N/A | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |