N
Patient 1
(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 7269835
- MDR report key
- 7269835
- Report number
- 1818910-2018-53416
- Event key
- 0
- Event type
- 3
- Date of event
- 2018-01-23
- Date received
- 2018-02-14
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 0
- Initial report to FDA
- 0
- Event location
- 3
Manufacturer Contact#
- Contact
- MR. CHAD GIBSON
- Address
- 700 ORTHOPAEDIC DRIVE WARSAW IN 46582 US
- Phone
- 574-574-5743
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | BIOSTOP G CEM RESTR 14MM | DEPUY CMW RESORBABLE BIOMATERIALS : CEMENT CENTRALIZER/PLUG | DEPUY ORTHOPAEDIC INC, 1818910 | JDK | 546314000 | 16F1306005 | Y | R |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2018-02-14 | 0 |
Event Narratives#
D
Patient 1
OCCURRENCE: CEMENT RESTRICTOR BREAKING AT THE TIME OF USE. DETAILS: ON (B)(6) 2018, IN THE TOTAL HIP ARTHROPLASTY SURGERY, USING THE 14 MM BIO CEMENT RESTRICTOR, IT WAS BROKEN. ACCORDING TO REPORTS THIS IS NOT THE FIRST TIME THIS HAPPENS. FOR THIS NEW EVENT, HE CALLED ATTENTION TO RECORD WHAT HAPPENED. IT WAS IDENTIFIED THAT THE INSTRUMENTS USED TODAY IN THE C-STEM AMT STEM BOX, "IS NOT COMPATIBLE WITH THE PLUG (CEMENT RESTRICTOR)". WE REQUEST CLARIFICATION AS TO THE INSTRUMENTS AND TECHNIQUES OF USE SO THAT THE PROBLEM DOES NOT HAPPEN AGAIN. PRODUCT AVAILABLE FOR ANALYSIS. PRODUCT INFORMATION: (B)(4) AND LOT: 16F1306005.
N
Patient 1
.
N
Patient 1
PRODUCT COMPLAINT # PC-(B)(4). INVESTIGATION SUMMARYEXAMINATION OF THE RETURNED DEVICE CONFIRMED THE REPORTED BREAKAGE. BASED ON THE PROVIDED INFORMATION AND THE PREFORMED INVESTIGATION, A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.