PINNACLE MTL INS NEUT36IDX52OD
Report
- Report Number
- 1818910-2014-23812
- Event Type
- Injury
- Date Received
- July 21, 2014
- Date of Event
- November 13, 2012
- Report Date
- November 13, 2012
- Manufacturer
- DEPUY INTERNATIONAL LTD. 8010379
- Product Code
- KWA
- PMA / PMN Number
- PK003523
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- PHYSICIAN
Narratives
(B)(4); THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
ON (B)(6) 2007 THE PATIENT GOT A NEW HIP IMPLANT. AFTER A WHILE SHE COMPLAINTS ABOUT PAIN. LABORATORY CONFIRMED THE MODERATE INCREASE IN METAL ION. AT THE (B)(6) 2012 SHE HAD ANOTHER OPERATION TO CHANGE THE IMPLANT. DURING THAT OPERATION THE DOCTOR NOTICED THAT THE WHOLE CUP WAS BLACK COLORED AND THERE WAS GREY LIQUID. 14 JULY 2014 - EMAIL SENT TO REQUEST TRANSLATION OF THE ATTACHED DOCUMENT. 15 JULY 2014 - RECEIVED QUOTE AND EMAILED AFFILIATE TO FIND OUT WHAT SPECIFIC PAGES NEED TO BE TRANSLATED. 15 JULY 2014 - RECEIVED PAGE NUMBERS AND RESENT FOR TRANSLATION. 24 JULY - TRANSLATED DOCUMENTS RECEIVED AND ATTACHED TO COMPLAINT. THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT AND LOT COMBINATIONS. REQUESTS FOR ADDITIONAL INVESTIGATIONAL INPUTS WERE MADE IN ACCORDANCE WITH WI-7915 APPENDIX A. MEDICAL RECORDS WERE OBTAINED AND REVIEWED BY A MEDICAL PROFESSIONAL. FROM A MEDICAL PERSPECTIVE, BASED ON THE INFORMATION AVAILABLE, IT IS NOT POSSIBLE TO DETERMINE IF THE COMPLAINT IS PRODUCT RELATED. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO IDENTIFY ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.
ON (B)(6) 2007 THE PATIENT GOT A NEW HIP IMPLANT. AFTER A WHILE SHE COMPLAINTS ABOUT PAIN. LABORATORY CONFIRMED THE MODERATE INCREASE IN METAL ION. AT THE (B)(6) 2012 SHE HAD ANOTHER OPERATION TO CHANGE THE IMPLANT. DURING THAT OPERATION, THE DOCTOR NOTICED THAT THE WHOLE CUP WAS BLACK COLORED AND THERE WAS GREY LIQUID THE REPORTED EVENT HAS BEEN EVALUATED AND WILL BE MONITORED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. 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.
THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
ON (B)(6) 2007 THE PATIENT GOT A NEW HIP IMPLANT. AFTER A WHILE, SHE COMPLAINTS ABOUT PAIN. LABORATORY CONFIRMED THE MODERATE INCREASE IN METAL ION. AT THE (B)(6) 2012 SHE HAD ANOTHER OPERATION TO CHANGE THE IMPLANT. DURING THAT OPERATION, THE DOCTOR NOTICED THAT THE WHOLE CUP WAS BLACK COLORED AND THERE WAS GREY LIQUID.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 424723 | PINNACLE MTL INS NEUT36IDX52OD | HIP ACETABULAR INSERT/LINER | KWA | DEPUY INTERNATIONAL LTD. 8010379 | 2272939 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 44 YR | Required Intervention |