FDA Adverse Event
Injury
Summary report: N
SUBCHONDROPLASTY
MDR report key: 7118206
·
Received December 14, 2017
Report
- Report Number
- 3008812173-2017-00029
- Event Type
- Injury
- Date Received
- December 14, 2017
- Date of Event
- November 18, 2014
- Report Date
- March 6, 2018
- Manufacturer
- ZIMMER KNEE CREATIONS, INC.
- Product Code
- OJH
- PMA / PMN Number
- PN/A
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THIS COMPLAINT IS DRIVEN FROM A CLINICAL STUDY; THE PATIENT RECEIVED AN OSTEOCHONDRAL ALLOGRAFT AFTER RECEIVING SCP. THE HCP STATED THE AE WAS POSSIBLY RELATED TO THE DEVICE AND PROCEDURE. IN AN EFFORT TO BE CONSERVATIVE, THIS COMPLAINT WILL BE TREATED AS A SERIOUS INJURY AND WILL BE INVESTIGATED FURTHER
Additional Manufacturer Narrative · 1
PER INVESTIGATION OF THE OPERATIVE NOTES, THE PATIENT REPORTED SHE WAS DOING ACCEPTABLY WELL UNTIL SHE FELL. THE FALL HAD CAUSED INCREASE PAIN AND THE NEED FOR AN ADDITIONAL SURGERY.
Description of Event or Problem · 1
CLINICAL SUBJECT RECEIVED OSTEOCHONDRAL ALLOGRAFT AFTER SCP.
Description of Event or Problem · 1
CLINICAL SUBJECT RECEIVED OSTEOCHONDRAL ALLOGRAFT AFTER SCP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 898863 | SUBCHONDROPLASTY | SCP KIT | OJH | ZIMMER KNEE CREATIONS, INC. | N/A | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 21 YR | Other |