REVITAN DIST. CURVED 16/200
Report
- Report Number
- 0009613350-2018-01062
- Event Type
- Injury
- Date Received
- October 5, 2018
- Date of Event
- September 10, 2018
- Report Date
- December 31, 2018
- Manufacturer
- ZIMMER GMBH
- Product Code
- KWA
- PMA / PMN Number
- PN/A
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- PHYSICIAN
Narratives
THIS FOLLOW-UP REPORT IS BEING FILLED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF INITIAL MEDWATCH. NEW INFORMATION RECEIVED: DEVICE WILL RETURN FOR INVESTIGATION; THE PLANNED REVISION ON THE (B)(6) 2018 TOOK PLACE; A BIOLOX DELTA HEAD BELONGS TO THIS COMPLAINT AND WILL ALSO BE PROVIDED FOR INVESTIGATION; DEVICE IDENTIFICATION NUMBER ISN'T READABLE; NO PIECES OF THE BROKEN DEVICE ARE REMAINING IN THE PATIENT; THE CLINIC DOESN'T HAVE THE EXACT IMPLANTATION DATE OF THE INITIAL PROCEDURE; THE PLANNED REVISION ON THE (B)(6) 2018 IS THE SECOND REVISION OF THE PATIENT; NO REPORTS AVAILABLE; NO X-RAYS AVAILABLE; THERE WAS NO DELAY TO THE PROCEDURE; THERE WEREN'T ANY CONTRIBUTING CONDITIONS RELATED TO THE EVENT. CONCOMITANT MEDICAL PRODUCTS ACCORDING D11: ITEM #: 01.00402.055, ITEM: REVITAN, PROXIMAL PART, CYLINDRICAL, UNCEMENTED, 55, LOT #: UNKNOWN. ITEM #: 00-8775-032-01, ITEM: BIOLOX DELTAHD 12/14 32X-3.5, LOT #: UNKNOWN. INVESTIGATION OF THIS INCIDENT IS CURRENTLY ONGOING, A FOLLOW UP REPORT WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. ZIMMER BIOMET¿S REFERENCE NUMBER OF THIS FILE IS (B)(4).
IT WAS NOW REPORTED THAT THE PLANNED REVISION ON THE (B)(6) 2018 TOOK PLACE.
CONCOMITANT MEDICAL PRODUCTS: ITEM# 01.00402.055, ITEM: REVITAN, PROXIMAL PART, CYLINDRICAL, UNCEMENTED, 55, TAPER 12/14, LOT#: UNKNOWN. UDI #: (B)(4). THIS PRODUCT IS MANUFACTURED BY ZIMMER BIOMET (B)(4) IS NOT CLEARED OR DISTRIBUTED IN THE U.S. HOWEVER, THIS REPORT IS BEING SUBMITTED AS ZIMMER BIOMET (B)(4) MANUFACTURES A SIMILAR DEVICE THAT IS CLEARED OR DISTRIBUTED IN THE UNITED STATES UNDER 510(K) NUMBER K071723. THE MANUFACTURER DID NOT RECEIVE X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. THE MANUFACTURER DID NOT RECEIVE THE DEVICE FOR INVESTIGATION. AS NO LOT NUMBER WAS PROVIDED, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. AN E-MAIL REQUESTING THE FOLLOWING ADDITIONAL INFORMATION WAS SENT ON OCTOBER 02, 2018 TO THE APPROPRIATE REPRESENTATIVES. ANY DEVICE IDENTIFICATION(S) AND CONTROL NUMBER(S) USED (LOT NUMBER); THE AVAILABILITY OF THE AFFECTED PRODUCT(S) (NON-AVAILABILITY WITH A RATIONALE) - POST PLANNED REVISION ON (B)(6) 2018. (B)(4). A MORE IN DEPTH EXPLANATION TO THE NATURE AND DETAILS OF THE COMPLAINT. ARE ANY PIECES OF THE BROKEN DEVICE REMAINING IN THE PATIENT (SPLITTERS ETC.)? THE EXACT IMPLANTATION DATE OF THE COMPLAINED EVENT ¿ (B)(6) 2016 IS GIVEN ON THE PER. THE INITIAL IMPLANTATION DATE. IS THE PLANNED REVISION ON THE (B)(6) 2018 THE 2ND REVISION OF THE PATIENT? IMPLANTATION REPORT OF THE 1ST REVISION (IF APPLICABLE). SURGICAL REPORT - POST PLANNED REVISION ON (B)(6) 2018. REVISION REPORT - POST PLANNED REVISION ON (B)(6) 2018. OTHER REPORTS (SPECIFY). ALL AVAILABLE X-RAYS DURING TIME IN- VIVO WITH PRINTED DATE. ALL AVAILABLE INTRAOPERATIVE PICTURES - POST PLANNED REVISION ON (B)(6) 2018. DID A DELAY IN THE PROCEDURE OVER 30 MINUTES OCCUR THAT WAS RELATED TO THE EVENT? TIME SURGERY WAS EXTENDED. WERE THERE ANY CONTRIBUTING CONDITIONS RELATED TO THE EVENT? (EX: TRAUMA, ILLNESS, PREVIOUS SURGERY, RELATED NON-COMPLIANCE, PATIENT ANATOMY). A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. AS SOON AS SUPPLEMENTAL INFORMATION BECOMES AVAILABLE AN UPDATED REPORT WILL BE SUBMITTED. ZIMMER BIOMET¿S REFERENCE NUMBER OF THIS FILE IS (B)(4).
INVESTIGATION RESULTS WERE MADE AVAILABLE. ASSOCIATED DEVICES: ITEM# 01.00402.055, REVITAN, PROXIMAL PART, CYLINDRICAL, UNCEMENTED, 55, TAPER 12/14, LOT#: 2819993. ITEM# 00-8775-032-01, BIOLOX DELTA HD 12/14 32X-3.5, LOT#: 2795878. DEVICE HISTORY RECORDS (DHR): THE DEVICE MANUFACTURING QUALITY RECORDS INDICATE THAT THE RELEASED COMPONENTS MET ALL REQUIREMENTS TO PERFORM AS INTENDED. TREND ANALYSIS: NO TREND CONSIDERING THE FOLLOWING EVENT IS IDENTIFIED: FRACTURE OF STEM. REVIEW OF EVENT DESCRIPTION: THE REVITAN STEM WAS REVISED AFTER APPROXIMATELY 2 YEARS AND 6 MONTHS IN VIVO BECAUSE OF ITS FRACTURE. REVIEW OF RECEIVED DATA: NO MEDICAL DATA WERE RECEIVED. DEVICES ANALYSIS: VISUAL EXAMINATION: THE CONNECTION PIN OF THE REVITAN STEM IS FRACTURED IN THE NON-BLASTED AREA. THE FRACTURE IS LOCATED APPROXIMATELY 1 TO 2 MM BELOW THE PROXIMAL END OF THE DISTAL PART. THE PROXIMAL PART OF THE CONNECTION PIN IS STILL ASSEMBLED TO THE PROXIMAL PART OF THE REVITAN STEM. THE FRACTURE SURFACES SHOW A FATIGUE FRACTURE STARTING FROM THE LATERAL SIDE. THE MEDIAL END OF THE FRACTURE SURFACES IS POLISHED TO A SHINE. ON THE DISTAL FRACTURE SURFACE SOME SCRATCHES CAN BE OBSERVED AS WELL. MACROSCOPICALLY, AS FAR AS VISIBLE, NO DEFECTS THAT COULD HAVE TRIGGERED OR FAVORED THE FRACTURE WERE FOUND ON THE FRACTURE SURFACES. ON THE PROXIMAL PART OF THE REVITAN STEM SEVERAL SCRATCHES AND NICKS CAN BE OBSERVED. THESE DERIVED MOST PROBABLY FROM THE REVISION SURGERY. THERE ARE NO SIGNS OF BONE ONGROWTH ON THE ANCHORING SURFACE OF THE PROXIMAL STEM PART. THE DISTAL END OF THE ANCHORING SURFACE ON BOTH THE MEDIAL AND LATERAL SIDE OF THE PROXIMAL STEM PART IS POLISHED. ON THE ANTEROLATERAL OR POSTEROLATERAL SIDE (IMPLANT POSITION IS UNKNOWN) PROXIMAL TO THIS POLISHED SURFACE A WORN REGION CAN BE OBSERVED. ON THE PROXIMAL FRACTURE PART OF THE CONNECTION PIN THERE IS A HALF CIRCUMFERENTIAL STRIPE REVEALING SURFACE CHANGES ADJACENT TO THE FRACTURE SURFACE. CLOSER INSPECTION OF THE STRIPE WITH A LOW POWER MICROSCOPE (LEICA MZ16 A, EQ-ID) REVEALED SMEARED MATERIAL AND FEW SIGNS OF FRETTING. ADJACENT TO THE STRIPE JOINS THE ORIGINAL SURFACE FOLLOWED BY THE BLASTED AREA. ON THE DISTAL HALF OF THE DISTAL PART OF THE REVITAN STEM BONE ATTACHMENTS ARE VISIBLE. REMOVAL DAMAGE IN THE FORM OF SCRATCHES, NICKS AND A BORE HOLE CAN BE RECOGNIZED ON THE ANCHORING SURFACE. THE FACE SURFACE OF THE ANTERIOR OR POSTERIOR NOSE IS POLISHED. CLOSE TO THIS NOSE SOME DAMAGE CAN BE SEEN ON THE FACE SURFACE OF THE STEM. SLIGHT METALLIC SMEARING CAN BE NOTICED ON THE ARTICULATION SURFACE AND ON THE BOTTOM BEVEL OF THE HEAD. THIS DERIVED PROBABLY FROM THE REVISION SURGERY. THE REVITAN STEM WAS REVISED AFTER APPROXIMATELY 2 YEARS AND 6 MONTHS IN VIVO BECAUSE OF ITS FRACTURE. THE LATTER OCCURRED DUE TO FATIGUE IN THE NON-BLASTED AREA OF THE CONNECTION PIN SOME MILLIMETERS BELOW THE PROXIMAL END OF THE DISTAL PART. THE FRACTURE STARTED ON THE LATERAL SIDE OF THE PIN. MACROSCOPICALLY, AS FAR AS VISIBLE, NO DEFECTS THAT COULD HAVE TRIGGERED OR FAVORED THE FRACTURE COULD BE FOUND ON THE FRACTURE SURFACES. ON THE PROXIMAL FRACTURE PART OF THE PIN THERE IS A HALF CIRCUMFERENTIAL STRIPE REVEALING A MIXTURE OF SURFACE CHANGES. IT IS UNKNOWN IF THESE SURFACE CHANGES EXISTED ALREADY BEFORE THE START OF THE FRACTURE OR DEVELOPED EXCLUSIVELY AS A CONCOMITANT PHENOMENON. BONE ATTACHMENTS COULD BE OBSERVED ON THE DISTAL HALF OF THE DISTAL PART OF THE REVITAN STEM BUT NOT ON THE PROXIMAL PART. FURTHER, SEVERAL POLISHED AREAS WERE OBSERVED ON THE PROXIMAL PART WHICH COULD PROBABLY INDICATE LOOSENING / MOVEMENTS BETWEEN THE PART AND THE SURROUNDINGS. THE WORN AREA OBSERVED ON THE ANTEROLATERAL OR POSTEROLATERAL SIDE (IMPLANT POSITION IS UNKNOWN) OF THE PROXIMAL STEM PART COULD POSSIBLY DERIVE FROM CONTACT WITH DEVICES USED FOR OSTEOSYNTHESIS. THESE FINDINGS COULD PROBABLY POINT TO A SUBOPTIMAL PROXIMAL BONE SUPPORT. HOWEVER, AS THE X-RAY FOLLOW-UP IS NOT AT HAND, THE BONE SITUATION IMMEDIATELY AFTER THE IMPLANTATION AND HOW IT DEVELOPED OVER TIME IN VIVO STAYS UNKNOWN. FURTHER, WITH NO PATIENT INFORMATION AT HAND (E.G. AGE, GENDER, BMI, BEHAVIOR (LEVEL OF PHYSICAL ACTIVITY), MEDICAL HISTORY ETC.) ANY INFLUENCING FACTORS THAT MAY RESULT FROM IT REMAIN UNKNOWN. THE REVITAN REVISION STEM SYSTEM PACKAGE INSERT THAT ACCOMPANIED THE REVITAN STEM PARTS POINTS TO THESE FACTS UNDER THE WARNINGSSECTION: HEAVY PATIENTS WHO ENGAGE IN HIGH LEVELS OF PHYSICAL ACTIVITY AND WHO DO NOT HAVE PROXIMAL BONE SUPPORT, ESPECIALLY MEDIALLY, ARE SUBJECT TO A RISK OF IMPLANT FAILURE WHEN A MODULAR REVISION STEM IS USED. IN SUCH CASES THE SURGEON SHOULD CONSIDER SURGICAL OPTIONS TO ENSURE PROXIMAL BONE SUPPORT OR SWITCHING TO A MONOBLOC REVISION STEM. BASED ON THE RETRIEVAL INVESTIGATION AND THE RECEIVED INFORMATION NO FURTHER CONCLUSIONS CAN BE DRAWN AND THE REASON FOR THE FRACTURE STAYS UNKNOWN. CORRECTIVE AND/OR PREVENTIVE ACTIONS HAVE BEEN INITIATED TO PREVENT REOCCURRENCE OF POTENTIAL PIN BREAKAGES OF THE REVITAN REVISION HIP SYSTEM IN THE FUTURE. ZIMMER (B)(4) DECIDED TO INITIATE A FIELD ACTION IN ORDER TO PROACTIVELY INFORM THE SURGEONS ABOUT HIGH RISK PATIENTS AS THEY MIGHT NOT BE AWARE OF THE EXPLICIT WARNING IN THE IFU. THE ACTION WAS INITIATED ON JANUARY 13TH 2017. AS THE ACTUAL DEVICE REPORTED IN SECTION D IS NOT MARKETED IN USA, THE USA/FDA IS NOT AFFECTED FROM THIS NOTIFICATION. ZIMMER BIOMET'S REFERENCE NUMBER OF THIS FILE IS (B)(4).
IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED WITH REVITAN DIST. CURVED 16/200. SUBSEQUENTLY, APPROXIMATELY 2 YEARS AND 5 MONTHS POST IMPLANTATION THE STEM FRACTURED. IT WAS ALSO REPORTED THAT A REVISION SURGERY IS PLANNED DUE TO FRACTURE OF THE STEM. ADDITIONAL INFORMATION HAS BEEN REQUESTED. NOTE: IMPLANTATION DATE HAS BEEN ASSUMED TO BE THE LAST DAY OF (B)(6) 2016, AS THE EXACT DATE WASN'T PROVIDED. EXPLANTATION DATE HAS BEEN ASSUMED AS THE DATE MENTIONED FOR THE PLANNED REVISION SURGERY.
NO EVENT UPDATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 779301 | REVITAN DIST. CURVED 16/200 | N/A | KWA | ZIMMER GMBH | N/A | 2838236 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |