BIOLOX PROSTHESIS HEAD 12/14 32MM L

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: D9 - PRODUCT RETURNED. H3 - YES, EVALUATION. H6 - CODES UPDATED. INVESTIGATION RESULTS: THE COMPLAINED PRODUCT WAS MADE AVAILABLE FOR INVESTIGATION. THE EXPLANTS 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. FEMORAL HEAD: THE EXPECTED PRIMARY METAL TRANSFER CANNOT BE FOUND EQUALLY DISTRIBUTED ON THE CONICAL BORE SURFACE OF THE FEMORAL HEAD. HOWEVER, THE PRIMARY METAL TRANSFER CANNOT BE EVALUATED SUFFICIENTLY DUE TO OVERLAYING METAL TRANSFER AND SECONDARY SURFACE DETERIORATION. DUE TO SECONDARY DAMAGE AND MISSING FRAGMENTS, THE PRIMARY FRACTURE SURFACE AND THE FRACTURE ORIGIN CANNOT BE IDENTIFIED. INSERT: PRIMARY METAL TRANSFER CAN BE FOUND ON THE TAPER OF THE FRAGMENT AS SHORT CIRCUMFERENTIAL LINES INSTEAD OF SMALL DOTS. THIS ABNORMAL METAL TRANSFER PATTERN INDICATES AT LEAST A PARTIAL ROTATION OF THE INSERT IN THE METAL CUP. HOWEVER, IT CANNOT BE CONCLUSIVELY DETERMINED WHETHER THIS METAL TRANSFER OCCURRED PRIOR TO OR AFTER THE PRIMARY FRACTURE EVENT. DUE TO SECONDARY DAMAGE AND MISSING FRAGMENTS, THE PRIMARY FRACTURE SURFACE AND THE FRACTURE ORIGIN CANNOT BE IDENTIFIED. METAL ABRASIONS ON THE POLISHED SURFACE OF THE CERAMIC INSERT INDICATE INTENSIVE CONTACT WITH THE METAL STEM AFTER THE FRACTURE EVENT OF THE FEMORAL HEAD. BATCH HISTORY REVIEW: THE DEVICE HISTORY RECORDS HAVE BEEN CHECKED FOR ALL LEADING DEVICE(S) LOT NUMBERS AND THE PRODUCTS FOUND TO BE ACCORDING TO SPECIFICATION VALID AT THE TIME OF PRODUCTION. FOR THIS COMPLAINT: THERE ARE NO SIMILAR COMPLAINTS AGAINST THE SAME LOT NUMBER(S) WITH THIS ERROR PATTERN. FOR THE LINKED COMPLAINT: THERE ARE TWO SIMILAR COMPLAINTS AGAINST THE SAME LOT NUMBER(S). 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: THE DENSITY OF THE FEMORAL HEAD AND OF THE INSERT WAS ANALYSED AND FOUND TO COMPLY WITH THE DELIVERY SPECIFICATION FOR BIOLOX®FORTE COMPONENTS. THE MICROSTRUCTURE AS OBTAINED FROM THE QUALITY DOCUMENTS OF BOTH COMPONENTS MEETS THE REQUIREMENTS AS SPECIFIED AT THE TIME OF PRODUCTION, TOO. THERE IS NO INDICATION OF ANY PRE-EXISTING MATERIAL DEFECT. SECONDARY METAL TRANSFER PATTERNS CAN BE LOCATED ON THE FRAGMENTS OF THE INSERT AND ON THE FRAGMENTS OF THE FEMORAL HEAD AS A RESULT OF CONTACT WITH METAL PARTS AND/ OR SURGICAL INSTRUMENTS. ON THE INNER SPHERE OF THE INSERT AND ON THE POLISHED SURFACE OF ALL THREE LARGE FRAGMENTS OF THE FEMORAL HEAD, AREAS WITH INCREASED WEAR CAN BE FOUND. IT IS LIKELY THAT MOST OF THESE AREAS WITH INCREASED WEAR WERE CAUSED PRIOR TO THE FRACTURE EVENT BY MICRO SEPARATION/ EDGE LOADING. HOWEVER, IT CANNOT BE DETERMINED CONCLUSIVELY WHETHER ANY OF THESE AREAS DEVELOPED FURTHER FOLLOWING THE PRIMARY FRACTURE EVENT. NO CONCLUSION CAN BE DRAWN AS TO WHICH COMPONENT (FEMORAL HEAD OR INSERT) FRACTURED FIRST. BASED ON THE PROVIDED FRAGMENTS, NO CONCLUSION CAN BE DRAWN REGARDING A POSSIBLE CAUSE FOR THE FRACTURE OF THE FEMORAL HEAD AND THE INSERT. BASED UPON THE INVESTIGATION RESULTS, A CAPA IS NOT NECESSARY.

Description of Event or Problem

OTHER LEADING MATERIAL - NOT SOLD TO US: NH103/ SC/MSC CERAMICS INSERT 32MM 52/54 SYM. (AESCULAP AG REFERENCE NO. (B)(4)). INVOLVED COMPONENTS: NH052T - PLASMACUP SC SIZE 52MM (AESCULAP AG REFERENCE NO. (B)(4)). NC089K - METHA NECK 12/14 135°/7.5°L RETRO-R ANTE (AESCULAP AG REFERENCE NO. (B)(4)). NC084T - METHA SHORT HIP STEM CAP SIZE 4 (AESCULAP AG REFERENCE NO. (B)(4)).

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 THE PRODUCT NK562 - BIOLOX PROSTHESIS HEAD (B)(6) 32MM L. ACCORDING TO THE COMPLAINT DESCRIPTION, THE PATIENT TWISTED HER HIP WHILE SITTING DOWN AND FELT A CRACKING SENSATION. PATIENT DIAGNOSED WITH A FRACTURE OF THE CERAMIC HEAD AND A DEFECTIVE CERAMIC INLAY. THESE CERAMIC COMPONENTS WERE REPLACED DURING SURGERY. REVISION SURGERY WAS PERFORMED 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 NOR AVAILABLE. THE ADVERSE EVENT IS FILED UNDER AESCULAP AG REFERENCE NO. (B)(4). OTHER LEADING MATERIAL - NOT SOLD TO US: NH103/ SC/MSC CERAMICS INSERT 32MM 52/54 SYM. (AESCULAP AG REFERENCE NO. (B)(4)). INVOLVED COMPONENTS: NH052T - PLASMACUP SC SIZE 52MM (AESCULAP AG REFERENCE NO. (B)(4)). NC089K - METHA NECK 12/14 135°/7.5°L RETRO-R ANTE (AESCULAP AG REFERENCE NO. (B)(4)). NC084T - METHA SHORT HIP STEM CAP SIZE 4 (AESCULAP AG REFERENCE NO. (B)(4)).