MAUDE Adverse Event Report: AESCULAP AG BIOLOX PROSTHESIS HEAD 8/10 32MM L; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Model Number	NJ108
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	11/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.
Event or Problem Description
It was reported to aesculap ag that a biolox prosthesis head (part # nj108) was used during a total hip arthroplasty procedure of the right leg.The first implantation surgery was performed on (b)(6) 2008 at (b)(6) hospital.According to the complainant, on (b)(6) 2020, the ceramic implant was confirmed as being fractured, which resulted in a revision surgery being scheduled, and then performed on (b)(6) 2020.Both the ceramic insert and the femoral head were found to be broken.The patient had undergone a computerized tomography (ct) scan to confirm the break prior to the revision surgery.Additionally, the ceramic implants were noted as having been broken approximately two (2) weeks before the revision surgery.The device is available to be returned to the manufacturer for evaluation.Although the patient experienced hip pain as a result of the break, the patient was able to walk "as usual." no further patient information has been made available.Additional information has been requested, but has not been made available.The adverse event / malfunction is filed under aag reference (b)(4).Involved components: nh102-sc/msc ceramics insert 32mm 48/50 sym - lot # 51450162.
Additional Manufacturer Narrative
Additional information - block d9.Manufacturer evaluation: the complaint device was returned to the manufacturer for evaluation.A visual examination revealed that two large fragments of a ceramic ball head were received.The density was determined on the fragments of the ball head; the measured density of the part complies with the delivery specification.The ceramic ball head cannot be completely reconstructed from the delivered fragments.There are fragments missing which could potentially yield further information if they were available.Therefore, the analysis of the fragments and the fracture surfaces remains technically incomplete.Additionally, there are metal transfer patterns of erratic appearance on the polished surface and on the fracture surfaces.This secondary metal transfer was probably produced by chafing between the metal parts and the ceramic fragments after the primary fracture event and during the surgical procedures.Such patterns do not provide any information about the cause of the fracture.In case of a symmetrical taper fit between the ceramic ball head and the metal taper, thin concentric lines (primary metal transfer) are expected over the whole circumference.The primary metal transfer cannot be found on the cone of the ball head.This may indicate a disturbance at the interface between stem and ball head.Additionally, metal transfer was observed; however, it cannot be determined whether this metal transfer occurred prior to or after the primary fracture event.If the primary fracture event is caused by hoop stresses inside the conical bore of the ceramic ball head, the primary fracture surface coincides with the ball head axis.Additionally, its appearance is very smooth and flat.One of the primary fracture surfaces can be identified.The fracture origin cannot be determined due to the referenced secondary damage.On the polished surface of the fragments of the ball head a multitude of small breakouts and metal abrasion can be found.The occurrence of these breakouts is a consequence of recurring contacts with ceramic fragments potentially prior to the fracture event of the ball head.The device quality and manufacturing history records (dhr) have been checked for the reported lot number and the products found to be according to our specification valid at the time of production.There are no similar complaints against the same lot number with this error pattern.The root cause of the problem was determined as being most likely cause by device usage.

• Brand Name: BIOLOX PROSTHESIS HEAD 8/10 32MM L
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 10924885
• Report Number: 9610612-2020-00846
• Device Sequence Number: 16778853
• Product Code: LZO
• UDI-Device Identifier: 04038653304356
• UDI-Public: 4038653304356
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K042344
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/30/2012
• Device Model Number: NJ108
• Device Catalogue Number: NJ108
• Device Lot Number: 51450171
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/02/2020
• Supplement Date Received by Manufacturer: 03/03/2021
• Initial Report FDA Received Date: 12/01/2020
• Supplement Report FDA Received Date: 04/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NH102 SC/MSC CERAMICS INSERT 32MM 4 LOT #51450162; NH102 SC/MSC CERAMICS INSERT 32MM 4 LOT #51450162
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR