TOTAL ASR ACET IMP SIZE 50
Report
- Report Number
- 1818910-2011-02631
- Event Type
- Injury
- Date Received
- March 2, 2011
- Date of Event
- February 6, 2011
- Report Date
- May 13, 2014
- Manufacturer
- DEPUY INTL., LTD. - 8010379
- Product Code
- KWA
- PMA / PMN Number
- NA
- Removal / Correction Number
- Z-1749/1816-2011
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- UNKNOWN
Narratives
THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.
THE ASR PLATFORM WAS VOLUNTARILY RECALLED FROM THE MARKET IN AUGUST 2010, AND THE ASR PRODUCT CODES ARE NOW CONSIDERED INACTIVE. FURTHER INVESTIGATION OF THIS INDIVIDUAL INCIDENT WILL NOT BE UNDERTAKEN, AS THERE IS AN ONGOING INVESTIGATION REGARDING THE ROOT CAUSE(S) AND/OR CORRECTIVE ACTIONS. (B)(4). DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED. THE CORRECTION/REMOVAL REPORTING NUMBER LISTED APPLIES TO THE CORRESPONDING PRODUCT CODE SOLD DOMESTICALLY.
DEPUY STILL CONSIDERS THE INVESTIGATION CLOSED.
THE ASR PLATFORM WAS VOLUNTARILY RECALLED FROM THE MARKET IN AUGUST 2010, AND THE ASR PRODUCT CODES ARE NOW CONSIDERED INACTIVE. FURTHER INVESTIGATION OF THIS INDIVIDUAL INCIDENT WILL NOT BE UNDERTAKEN, AS THERE IS AN ONGOING INVESTIGATION REGARDING THE ROOT CAUSE(S) AND/OR CORRECTIVE ACTIONS. (B)(4).
IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. DEPUY STILL CONSIDERS THIS CASE CLOSED TO CAPA.
IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. DEPUY STILL CONSIDERS THIS CASE CLOSED TO CAPA.
UPDATE: LEFT HIP REVISION, DATE AND REASON OF REVISION. REASON FOR REVISION: ALVAL / SOFT TISSUE REACTION.
NEW ETQ RECORD CREATED IN ORDER TO UPDATE ETQ (LEGACY SYSTEM) (B)(4). REASON FOR ORIGINAL COMPLAINT: ASR XL ACETABULAR SYSTEM (RIGHT): RECOMMENDED. UPDATE: 19TH JULY 2012: CONFIRM IT WAS A LEFT HIP REVISION, PRODUCTS, SURGEON, DATE AND REASON OF REVISION UPDATED. UPDATE RECEIVED: 8TH JUNE 2013: AMENDED REVISION DATE - (B)(6) 2011. HIP(S) TO BE REVISED: LEFT REASON(S) FOR REVISION: ALVAL / SOFT TISSUE REACTION INCORRECT SEE BELOW UPDATE RECEIVED 3RD MARCH, 2014. NEW FIELDS COMPLETED. REASON FOR REVISION AMENDED. ADDITIONAL SURGEON AND HOSPITAL ADDED. SURGEON NAME AMENDED, REASON(S) FOR REVISION: PAIN.
NEW ETQ RECORD CREATED IN ORDER TO UPDATE ETQ (LEGACY SYSTEM) (B)(6). REASON FOR ORIGINAL COMPLAINT - ASR XL ACETABULAR SYSTEM (RIGHT) - RECOMMENDED. UPDATE: 19TH JULY 2012 - CONFIRM IT WAS A LEFT HIP REVISION, PRODUCTS, SURGEON, DATE AND REASON OF REVISION UPDATED. UPDATE RECEIVED: 8TH JUNE 2013 - AMENDED REVISION DATE - (B)(6) 2011. HIP(S) TO BE REVISED: LEFT REASON(S) FOR REVISION: ALVAL / SOFT TISSUE REACTION INCORRECT SEE BELOW. UPDATE RECEIVED 3RD MARCH, 2014. NEW FIELDS COMPLETED. REASON FOR REVISION AMENDED. ADDITIONAL SURGEON AND HOSPITAL ADDED. SURGEON NAME AMENDED UPDATE - AMENDED REVISION DATE TAKEN FROM CLAIMSUITE DATED 13TH MAY 2014.
THE PATIENT HAS BEEN RECOMMENDED FOR AN ASR REVISION. SPECIFIC DETAILS REGARDING THE REPORT ARE UNKNOWN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TOTAL ASR ACET IMP SIZE 50 | HIP ACETABULAR CUP | KWA | DEPUY INTL., LTD. - 8010379 | NA | 2203830 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Required Intervention |