N
Patient 1
PRODUCT COMPLAINT # (B)(4). INITIAL REPORTER OCCUPATION: LAWYER. (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
MAUDE MDR 9903556
- MDR report key
- 9903556
- Report number
- 1818910-2020-09725
- Event key
- 0
- Event type
- 3
- Date of event
- 2017-02-14
- Date received
- 2020-03-31
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- KARA DITTY-BOVARD
- Address
- 700 ORTHOPAEDIC DRIVE WARSAW IN 46581 US
- Phone
- 610-610-6107
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | UNKNOWN HIP ACETABULAR CUP | HIP ACETABULAR CUP | DEPUY ORTHOPAEDICS INC US | KWA | UNK HIP ACETABULAR CUP | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2020-03-31 | 0 | 1. R |
Event Narratives#
D
Patient 1
PCF AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF MEDICAL RECORDS PATIENT WAS REVISED TO ADDRESSED LEFT INFECTED TOTAL HIP ARTHROPLASTY OPERATIVE NOTES INDICATED SCARRING AND SMALL POSTERIOR SUPERIOR DEFECT. PATHOLOGY REPORT REPORTED OF PATCHY ACUTE AND CHRONIC INFLAMMATION. DOI: (B)(6) 2010, (CUP, STEM). DOI: (B)(6) 2016, (LINER & HEAD). DOR: (B)(6) 2017, LEFT HIP.