BIOLOX PROSTHESIS HEAD 12/14 28MM S

Description of Event or Problem

THE ADVERSE EVENT IS FILED UNDER AESCULAP AG REFERENCE NO. (B)(4) OTHER LEADING MATERIAL (NOT SOLD IN US): NH093/ SC/MSC CERAMICS INSERT 28MM 52/54 SYM. (AESCULAP AG REFERENCE NO. (B)(4)). INVOLVED COMPONENTS: NH052T/ PLASMACUP SC SIZE 52MM (AESCULAP AG REFERENCE NO. (B)(4)). NA778T/ PLASMACUP FIXATION SCREW 6.5X28MM (AESCULAP AG REFERENCE NO. (B)(4)). NK711T/ PLASMACUP FIXATION SCREW 6.5X28MM (AESCULAP AG REFERENCE NO. (B)(4)).

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: D9 - DEVICE RETURN. H3 - EVALUATION, YES. H6 - CODES UPDATED. INVESTIGATION RESULTS: THE COMPONENTS WERE SENT TO THE MANUFACTURER CERAMTEC FOR EXAMINATION. THE FOLLOWING EXAMINATIONS WERE CARRIED OUT: - IDENTIFICATION. - DENSITY AND GRAIN SIZE. - DESCRIPTION OF THE FRAGMENTS PROVIDED: RECONSTRUCTION, METAL TRANSFER, FRACTURE SURFACE. · THE DENSITY OF THE FEMORAL HEAD WAS ANALYSED AND FOUND TO COMPLY WITH THE DELIVERY SPECIFICATION FOR BIOLOX®FORTE COMPONENTS. THE MICROSTRUCTURE AS OBTAINED FROM THE QUALITY DOCUMENTS OF THE INSERT MEETS THE REQUIREMENTS AS SPECIFIED AT THE TIME OF PRODUCTION. BASED ON THE AVAILABLE INFORMATION THERE IS NO INDICATIONS OF ANY PRE-EXISTING MATERIAL DEFECT. · SECONDARY METAL TRANSFER PATTERNS CAN BE LOCATED ON THE INSERT AND ON THE FRAGMENTS OF THE FEMORAL HEAD MOST LIKELY AS A RESULT OF CONTACT WITH METAL PARTS AND/ OR SURGICAL INSTRUMENTS. · ON THE POLISHED SURFACE OF THE FRAGMENTS OF THE FEMORAL HEAD AND ON THE INNER SPHERE OF THE INSERT, A CLEARLY RESTRICTED AREA WITH INCREASED WEAR CAN BE FOUND. HOWEVER, IT CANNOT BE DETERMINED WHETHER THESE AREAS WERE GENERATED BY MICROSEPARATION/ EDGE LOADING PRIOR TO THE FRACTURE OR CAUSED BY CERAMIC FRAGMENTS AND THIRD BODY-WEAR AFTER THE FRACTURE EVENT. FEMORAL HEAD: · THE EXPECTED PRIMARY METAL TRANSFER CAN BE FOUND WITH VARYING INTENSITY ON THE CONICAL BORE SURFACE OF THE FEMORAL HEAD. · DUE TO SECONDARY DAMAGE AND MISSING FRAGMENTS, THE PRIMARY FRACTURE SURFACE AND THE FRACTURE ORIGIN CANNOT BE IDENTIFIED. INSERT: · PRIMARY REGULAR METAL TRANSFER CAN BE FOUND WITH VARYING INTENSITY ON THE TAPER OF THE INSERT. · METAL ABRASIONS ON THE POLISHED SURFACE OF THE CERAMIC INSERT INDICATE AN INTENSIVE CONTACT WITH THE METAL STEM AFTER THE PRIMARY FRACTURE EVENT OF THE FEMORAL HEAD. BATCH HISTORY REVIEW: THE LOT NUMBER WAS NOT PROVIDED. ALSO, AFTER MEANINGFUL ATTEMPTS, NO FURTHER INFORMATION WAS RECEIVED. THE DEVICE HISTORY RECORDS HAVE BEEN CHECKED FOR ALL OTHER LOT NUMBERS AND THE PRODUCTS FOUND TO BE ACCORDING TO SPECIFICATION VALID AT THE TIME OF PRODUCTION. THERE ARE NO SIMILAR COMPLAINTS AGAINST THE SAME LOT NUMBER(S) WITH THIS ERROR PATTERN. REMARK: THE DATE OF MANUFACTURE OF THE ARTICLES INVOLVED FROM (AESCULAP AG INTERNAL REFERENCE NUMBERS) (B)(4) ARE ALL AFTER THE STATED IMPLANTATION YEAR OF 2003. ACCORDING TO MANUFACTURER'S REPORTING EVALUATION IN ACCORDANCE WITH 21 CFR PART 803, SECTION 803.3, THIS EVENT IS CONSIDERED REPORTABLE FOR THE FOLLOWING REASON - ADVERSE EVENT (NOT LATER THAN 30 DAYS). THE ASSESSMENT FOR THE REPORTABILITY OF THIS ADVERSE EVENT WAS BASED ON THE PATIENT HARM, REVISION SURGERY. CONCLUSION/ PREVENTIVE MEASURES: BASED ON THE CURRENT INFORMATION, A CLEAR CONCLUSION CANNOT BE DRAWN. THERE IS NO INDICATION FOR A DESIGN-, MANUFACTURING- AND/OR MATERIAL-RELATED FAILURE. BASED UPON THE INVESTIGATION RESULTS, A CAPA IS NOT REQUIRED.

Additional Manufacturer Narrative

MANUFACTURING SITE EVALUATION: INVESTIGATION ON-GOING. ADDITIONAL INFORMATION / INVESTIGATION RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

Description of Event or Problem

IT WAS REPORTED THAT THERE WAS AN ISSUE WITH NK460 - BIOLOX PROSTHESIS HEAD 12/14 28MM S. ACCORDING TO THE COMPLAINT DESCRIPTION, THERE WAS POSTOPERATIVE SPONTANEOUS FRACTURE OF THE CERAMIC HEAD WITH HORIZONTAL TOTAL HIP JOINT ENDOPROSTHESIS ON THE LEFT FROM 2003. THE REVISION OCCURRED ON (B)(6) 2025. ACCORDING TO MANUFACTURER'S REPORTING EVALUATION IN ACCORDANCE WITH 21 CFR PART 803, SECTION 803.3, THIS EVENT IS CONSIDERED REPORTABLE FOR THE FOLLOWING REASON - ADVERSE EVENT (NOT LATER THAN 30 DAYS). THE ASSESSMENT FOR THE REPORTABILITY OF THIS ADVERSE EVENT WAS BASED ON THE PATIENT HARM, REVISION SURGERY. ADDITIONAL INFORMATION WAS NOT PROVIDED. THE ADVERSE EVENT IS FILED UNDER AESCULAP AG REFERENCE NO. (B)(4). OTHER LEADING MATERIAL (NOT SOLD IN US): NH093/ SC/MSC CERAMICS INSERT 28MM 52/54 SYM. (AESCULAP AG REFERENCE NO. (B)(4)). INVOLVED COMPONENTS: NH052T/ PLASMACUP SC SIZE 52MM (AESCULAP AG REFERENCE NO. (B)(4)). NA778T/ PLASMACUP FIXATION SCREW 6.5X28MM (AESCULAP AG REFERENCE NO. (B)(4)). NK711T/ PLASMACUP FIXATION SCREW 6.5X28MM (AESCULAP AG REFERENCE NO. (B)(4)).