ASR TAP SLV ADAP 11/13 +3
Report
- Report Number
- 1818910-2014-28027
- Event Type
- Injury
- Date Received
- September 15, 2014
- Date of Event
- June 6, 2012
- Report Date
- April 1, 2015
- Manufacturer
- DEPUY INTERNATIONAL LTD. 8010379
- Product Code
- KXA
- Removal / Correction Number
- Z-1749/1816-2011
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- PATIENT
Narratives
ADDITIONAL NARRATIVE:IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.NO 510(K) NUMBER PROVIDED BECAUSE THIS IMPLANT IS SOLD INTERNATIONALLY WITH DIFFERENT INDICATIONS FOR USE; IT IS CURRENTLY SOLD IN THE US UNDER A DIFFERENT PART NUMBER. THE CORRECTION/REMOVAL REPORTING NUMBER LISTED APPLIES TO THE CORRESPONDING PRODUCT CODE SOLD DOMESTICALLY. 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.
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.
IMPLANT DATE. DEPUY STILL CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED THE INVESTIGATION WILL BE REOPENED.
ADDITIONAL NARRATIVE: 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.
ASR REVISION.ASR XL ACETABULAR SYSTEM - LEFT HIP.REASON(S) FOR REVISION: UNKNOWN.UPDATE - MARKED AS LEGAL, ADDED KID NUMBER, AMENDED IMPLANT DATE, ADDED A SLEEVE, FILED OUT MW FIELDS AND MANUFACTURING DATES. TAKEN FROM (B)(6) EMAIL AND SPREADSHEET BOTH DATED (B)(6) 2014.
ASR REVISION, ASR XL ACETABULAR SYSTEM - LEFT HIP, REASON(S) FOR REVISION: UNKNOWN. UPDATE - MARKED AS LEGAL, ADDED KID NUMBER, AMENDED IMPLANT DATE, ADDED A SLEEVE, FILED OUT MW FIELDS AND MANUFACTURING DATES. TAKEN FROM (B)(6) EMAIL AND SPREADSHEET BOTH DATED 9TH SEPTEMBER 2014. UPDATE - AMENDED IMPLANT DATE, ADDED ALL EXPIRY DATES, QUERYING MISSING STEM DETAILS AND MISSING REASON FOR REVISION. TAKEN FROM CLAIMSUITE DATED THE 31ST MARCH 2015. - AB 1ST APRIL 2014. SURGERY DATE: 09 MAY 2006 UPDATE - RECEIVED STEM DETAILS AND REASONS FOR REVISION ON 1ST APRIL 2015. 2ND REASON FOR REVISION ON CLAIMSUITE DATED 2ND APRIL 2015 REASONS FOR REVISION : HIGH COBALT AND CHROMIUM, PAIN AND LIMP, SIGNIFICANT EFFUSION. / ALVAL / SOFT TISSUE REACTION
ASR REVISION. ASR XL ACETABULAR SYSTEM - LEFT HIP. REASON(S) FOR REVISION: UNKNOWN. UPDATE - MARKED AS LEGAL, ADDED KID NUMBER, AMENDED IMPLANT DATE, ADDED A SLEEVE, FILED OUT MW FIELDS AND MANUFACTURING DATES. TAKEN FROM KENNEDYS EMAIL AND SPREADSHEET BOTH DATED (B)(6) 2014 UPDATE - AMENDED IMPLANT DATE, ADDED ALL EXPIRY DATES, QUERYING MISSING STEM DETAILS AND MISSING REASON FOR REVISION. TAKEN FROM CLAIMSUITE DATED THE (B)(6) 2015. - AB 1ST APRIL 2014 SURGERY DATE: (B)(6) 2006.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 569939 | ASR TAP SLV ADAP 11/13 +3 | HIP FEMORAL STEM/SLEEVE | KXA | DEPUY INTERNATIONAL LTD. 8010379 | 1843207 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |