REVITAN®, DISTAL PART, CURVED, UNCEMENTED, 22/200
Report
- Report Number
- 0009613350-2019-00248
- Event Type
- Injury
- Date Received
- April 24, 2019
- Date of Event
- March 27, 2019
- Report Date
- November 27, 2019
- Manufacturer
- ZIMMER GMBH
- Product Code
- KWA
- PMA / PMN Number
- N/A
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- PHYSICIAN
Narratives
INVESTIGATION RESULTS WERE MADE AVAILABLE. AS FOR ZIMMER SPECIALISTS TO PERFORM AN IN-DEPTH ANALYSIS IT IS REQUIRED TO HAVE ALL NECESSARY INFORMATION AT HAND, IT WAS THEREFORE TRIED SEVERAL TIMES TO RECEIVE ADDITIONAL INFORMATION FOR THIS CASE. CURRENTLY, ADDITIONAL INFORMATION IS NOT AVAILABLE. DHR REVIEW: AS NO LOT NUMBERS WERE PROVIDED FOR THE DEVICES, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. THE MISSING DEVICE INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE. AT ZIMMER GMBH ALL MEDICAL DEVICES PRIOR RELEASE TO MARKET UNDERGO SEVERAL QUALITY INSPECTIONS AS DEFINED IN OUR QUALITY PROCEDURES. OUR QUALITY INSPECTION- AND DEVIATION PROCEDURES ENSURE THAT ONLY PRODUCTS FULFILLING THE SPECIFICATION ARE SOLD. THESE PROCEDURES ARE PART OF THE OVERALL QUALITY MANAGEMENT SYSTEM AT ZIMMER GMBH AND GET REGULARLY AUDITED BY OUR NOTIFIED BODY, COMPETENT AUTHORITIES AND INTERNAL AND EXTERNAL AUDITORS. THUS, FOR ALL PRODUCTS SOLD TO THE MARKET CAN BE ASSUMED HAVING A COMPLETE AND CORRECT DHR. TREND ANALYSIS: ANALYSIS COULD NOT BE PERFORMED AS NO ITEM NUMBER IS AVAILABLE. EVENT DESCRIPTION: IT WAS REPORTED THAT THERE WAS A BROKEN CONE OF A REVITAN STEM. REVIEW OF RECEIVED DATA: NO MEDICAL DATA SUCH AS X-RAYS, SURGICAL NOTES OR ANY OTHER CASE-RELEVANT DOCUMENTS RECEIVED. DEVICES ANALYSIS: NO PRODUCT WAS RETURNED TO ZIMMER BIOMET FOR IN-DEPTH ANALYSIS. REVIEW OF PRODUCT DOCUMENTATION: - THIS DEVICE IS INTENDED FOR TREATMENT. CONCLUSION SUMMARY: IT WAS REPORTED THAT THE CONE OF A REVITAN STEM WAS BROKEN. THE IN VIVO TIME IS UNKNOWN. NEITHER X-RAYS, OPERATIVE NOTES, OFFICE VISIT NOTES, NOR DEVICES OR PHOTOS OF THE EXPLANTED IMPLANT WERE RECEIVED; THEREFORE THE CONDITION OF THE COMPONENT IS UNKNOWN. PATIENT FACTORS THAT MAY AFFECT THE PERFORMANCE OF THE COMPONENTS SUCH AS BONE QUALITY, ACTIVITY LEVEL, TYPE OF ACTIVITY (LOW IMPACT VS. HIGH IMPACT), AND RELEVANT MEDICAL HISTORY ARE UNKNOWN. ADHERENCE TO REHABILITATION PROTOCOL IS UNKNOWN. THE DHR CHECK COULD NOT BE PERFORMED AS THE LOT NUMBER WAS NOT AVAILABLE. THE INVESTIGATION RESULTS DID NOT IDENTIFY A NON-CONFORMANCE OR A COMPLAINT OUT OF BOX (COOB). BASED ON THE GIVEN INFORMATION AND THE RESULTS OF THE INVESTIGATION, THE COMPLAINT COULD NOT BE CONFIRMED AS THE ALLEGED FAILURE COULD NOT BE IDENTIFIED OR REPRODUCED. THE NEED FOR CORRECTIVE MEASURES IS NOT INDICATED AND ZIMMER GMBH CONSIDERS THIS CASE AS CLOSED. ZIMMER BIOMET'S REFERENCE NUMBER OF THIS FILE IS (B)(4).
THIS FOLLOW-UP REPORT IS BEING FILLED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE PREVIOUS MEDWATCH. 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. DHR REVIEW: THE DEVICE MANUFACTURING QUALITY RECORDS INDICATE THAT THE RELEASED COMPONENTS MET ALL REQUIREMENTS TO PERFORM AS INTENDED. TREND ANALYSIS: NO TRIGGER CONSIDERING THE FOLLOWING EVENT IS IDENTIFIED: IMPLANT BREAKAGE. NO LOT TRIGGER: NO SIMILAR INVESTIGATED EVENT FOR THE SAME LOT NUMBER 2720301 HAS BEEN FOUND. REVIEW OF EVENT DESCRIPTION: IT WAS REPORTED THAT THERE WAS A BROKEN CONE OF A REVITAN STEM. REVIEW OF RECEIVED PICTURES: ONLY PICTURES OF THE COMPONENTS ARE RECEIVED. THEREFORE, ONLY OBSERVATIONS CAN BE DOCUMENTED AND NO CONCLUSION CAN BE DRAWN. THE IMAGES HAVE A POOR QUALITY AND THEREFORE THE STATEMENTS ARE LIMITED. ON THE PICTURES IT IS CLEARLY VISIBLE THAT THE CONNECTION PIN OF THE REVITAN STEM IS FRACTURED. THE PROXIMAL FRACTURE PART OF THE CONNECTION PIN SEEMS TO BE STILL ASSEMBLED TO THE PROXIMAL PART OF THE REVITAN STEM. BOTH FRACTURE SURFACES SHOW PARTIAL POLISHING AND SLIGHT SCRATCHES. THE QUALITY OF THE PICTURES DOES NOT ALLOW A FURTHER DETERMINATION OF THE FRACTURE TYPE AND THE FRACTURE ORIGIN. ON THE DISTAL PART OF THE REVITAN STEM BONE ATTACHMENTS AND / OR TISSUE CAN BE OBSERVED IN THE HOLES FOR THE LOCKING SCREWS. REMOVAL DAMAGE IN THE FORM OF CUTS, SCRATCHES AND NICKS CAN ALSO BE RECOGNIZED. THE ANCHORING SURFACE OF THE PROXIMAL STEM PART EXHIBITS NO BONE ATTACHMENTS BUT DAMAGE DUE TO THE REMOVAL E.G. SCRATCHES AND INDENTS CAN BE OBSERVED. THE HEAD IS INCONSPICUOUS. REVIEW OF RECEIVED X-RAYS: 02.02.2015: LEFT HIP AP-VIEW: THE FEMORAL HEAD APPEARS SLIGHTLY DECENTERED. LEFT HIP LAUENSTEIN-VIEW: ANTEROLATERAL AT THE STEM SHOULDER RECOGNIZABLE RADIOLUCENT AREA, ALSO DORSOMEDIAL. PEDESTAL SIGN AT THE TIP OF THE STEM WITH A SMALL DISTANCE BETWEEN THE STEM TIP AND THE SCLEROSIS LINE. ON (B)(6) 2015: PELVIC OVERVIEW: SITUATION AFTER UNCEMENTED TOTAL HIP REPLACEMENT ON THE LEFT, INCLINATION ANGLE APPROXIMATELY 39 DEGREES. THE FEMORAL HEAD APPEARS UNCHANGED SLIGHTLY DECENTERED. RADIOLUENT AREA NEXT TO THE STEM PROXIMAL LATERAL. AT THE TIP OF THE STEM RECOGNIZABLE PEDESTAL SIGN. ON (B)(6) 2015: PELVIC AND IMAGE DETAIL FROM THE LEFT SIDE: SITUATION AFTER IMPLANTATION OF AN UNCEMENTED MODULAR PROSTHESIS STEM. INCLINATION ANGLE OF THE CUP APPROXIMATELY 38 DEGREES. IN THE AREA OF THE DISTAL PART OF THE STEM RECOGNIZABLE FOUR WIRE CERCLAGES. AT THE LEVEL OF THE PROXIMAL PART OF THE STEM RECOGNIZABLE RADIOLUCENT AREA MEDIAL, LATERALLY LIMITED BY A SCLEROTIC LINE. ON (B)(6) 2015: PELVIC OVERVIEW: COMPARED TO THE PREVIOUS X-RAY OF (B)(6) 2015 THE STEM APPEARS TO BE SLIGHTLY SUNKEN. IMAGE DETAIL FROM THE LEFT SIDE IN AP-VIEW: RECOGNIZABLE RADIOLUCENT AREA AT THE LEVEL OF THE PROXIMAL PART OF THE STEM MEDIALLY, ALSO LATERALLY LIMITED BY A SCLEROTIC LINE. LEFT HIP LAUENSTEIN-VIEW: COMPARED TO THE AP-VIEW NO ADDITIONAL SPECIAL FEATURES RECOGNIZABLE. ON (B)(6) 2019: PELVIC OVERVIEW: THE PROXIMAL PART OF THE STEM IS TILTED TO MEDIAL APPROXIMATELY 7 DEGREES. LATERAL OF THE PROXIMAL PART OF THE STEM SHARPLY DEMARCATED SCLEROSIS LINE RECOGNIZABLE. ABOVE THE CONNECTION POINT OF THE STEM AT THE LEVEL OF THE CALCAR A SMALL RADIOLUCENT AREA WITH A LIMITED SCLEROTIC LINE IS VISIBLE. SECOND VIEW: COMPARED TO THE AP-VIEW ADDITIONAL NARROW RADIOLUCENT LINE VISIBLE AT HEIGHT AND BELOW THE CONNECTION POINT MEDIAL. ON (B)(6) 2019: PELVIC OVERVIEW: SITUATION AFTER REVISION SURGERY. THE PERI-IMPLANT AREA OF THE PROXIMAL PART OF THE PROSTHESIS STEM APPEARS INCREASINGLY RADIOLUCENT, MEDIAL AND LATERAL LIMITED BY A SCLEROTIC LINE. COMPARED TO THE PREVIOUS X-RAYS UNCHANGED POSITION OF THE CUP. DEVICES ANALYSIS: NO PRODUCT WAS RETURNED TO ZIMMER BIOMET FOR IN-DEPTH ANALYSIS. REVIEW OF PRODUCT DOCUMENTATION: THIS DEVICE IS INTENDED FOR TREATMENT. THE COMPATIBILITY CHECK WAS PERFORMED AND SHOWED THAT THE PRODUCT COMBINATION WAS APPROVED BY ZIMMER BIOMET. CONCLUSION SUMMARY: IT WAS REPORTED THAT THE CONE OF A REVITAN STEM WAS BROKEN. THE IN VIVO TIME IS APPROX. 4-5 YEARS. NO PRODUCT WAS RETURNED TO ZIMMER BIOMET FOR IN-DEPTH ANALYSIS. SOME PICTURES FROM THE EXPLANTATION AND X-RAYS WERE AVAILABLE FOR THE INVESTIGATION. THE QUALITY RECORDS (DHR) SHOW THAT ALL SPECIFIED CHARACTERISTICS (MATERIAL, DIMENSIONS, SURFACE, ETC.) HAVE MET THE SPECIFICATIONS VALID AT THE TIME OF PRODUCTION. ON THE PICTURES IT IS CLEARLY VISIBLE THAT THE CONNECTION PIN OF THE REVITAN STEM IS FRACTURED. BOTH FRACTURE SURFACES SHOW PARTIAL POLISHING AND SLIGHT SCRATCHES. THE QUALITY OF THE PICTURES DOES NOT ALLOW A FURTHER DETERMINATION OF THE FRACTURE TYPE AND THE FRACTURE ORIGIN. AFTER RADIOLOGICAL EVIDENCE OF A SIGNIFICANT SINKING OF THE STEM AND A PRONOUNCED RADIOLUCENT AREA AROUND THE PROXIMAL PART OF THE STEM 6 WEEKS AFTER IMPLANTATION AS AN INDICATION OF INSUFFICIENT BONY SUPPORT, NO RADIOLOGICAL FOLLOW-UP IS AVAILABLE UNTIL THE RADIOLOGICAL DOCUMENTED FAILURE OF THE CONNECTION POINT OF THE REVITAN STEM. WHETHER THERE WAS EVIDENCE OF INSUFFICIENT BONY SUPPORT IN THE AREA OF THE PROXIMAL PART OF THE STEM AS A FACTOR CONTRIBUTING TO THE IMPLANT FAILURE IMMEDIATELY BEFORE THE FAILURE OF THE CONNECTION POINT OF THE STEM CANNOT BE RELIABLY ASSESSED RADIOLOGICALLY. THE INVESTIGATION RESULTS DID NOT IDENTIFY A NON-CONFORMANCE OR A COMPLAINT OUT OF BOX (COOB). HOWEVER, BASED ON THE AVAILABLE INFORMATION, AN EXACT ROOT CAUSE COULD NOT BE DETERMINED. 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 GMBH 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 GMBH CONSIDERS THIS CASE AS CLOSED. ZIMMER BIOMET'S REFERENCE NUMBER OF THIS FILE IS (B)(4).
CONCOMITANT MEDICAL PRODUCTS: REVITAN, PROXIMAL PART, CYLINDRICAL, UNCEMENTED, 55, TAPER 12/14. CATALOG NO#: 0100402055; LOT#: 2784429. COCR HEAD, XL, 32/+8, TAPER 12/14. CATALOG NO#: 0101012328; LOT#: 2786302. THERAPY DATE: (B)(6) 2019. THE MANUFACTURER RECEIVED X-RAYS, PHOTOS FOR REVIEW. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE AND / OR THE DEVICE(S) BE RETURNED FOR EVALUATION AND AN INVESTIGATION RESULT BE AVAILABLE, THAT CHANGES THIS ASSESSMENT, AN AMENDED MEDICAL DEVICE REPORT WILL BE SUBMITTED. ZIMMER¿S REFERENCE NUMBER OF THIS FILE IS (B)(4).
INVESTIGATION RESULTS ARE NOW AVAILABLE.
PLEASE REFER TO REPORT 0009613350 - 2019 - 00248.
NO EVENT UPDATE.
PATIENT WAS IMPLANTED ON THE LEFT SIDE AND UNDERWENT REVISION SURGERY DUE TO IMPLANT FRACTURE.
THE PRODUCT IN THIS REPORT IS NOT CLEARED OR DISTRIBUTED IN THE U.S. HOWEVER, THIS REPORT IS BEING SUBMITTED AS ZIMMER BIOMET WINTERTHUR MANUFACTURES A SIMILAR DEVICE THAT IS CLEARED OR DISTRIBUTED IN THE UNITED STATES UNDER 510(K) NUMBER K071723. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED. THE MANUFACTURER DID NOT RECEIVE X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. DEVICE HISTORY RECORD (DHR) REVIEW COULD NOT BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. 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).
IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION SURGERY DUE TO A BROKEN CONE OF A REVITAN STEM. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE AT THIS POINT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 339618 | REVITAN®, DISTAL PART, CURVED, UNCEMENTED, 22/200 | N/A | KWA | ZIMMER GMBH | N/A | 2720301 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R | UNKNOWN REVITAN PROXIMAL STEM| UNKNOWN REVITAN PROXIMAL STEM |