MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG CERAMIC CERAMIC INSERT STANDARD 44/36; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Catalog Number 75007454

Device Problems Fracture (1260); Off-Label Use (1494); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Failure of Implant (1924); Pain (1994); Discomfort (2330)

Event Date 03/29/2023

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event Description

It was reported that, ten years after a right thr done in 2012, where a ceramic ceramic insert standard 44/36 was implanted, the patient started noticing a creaking sound from their hip ((b)(6) 2022).After prolonged stress, pain then also occurred in the right hip.No trauma is remembered, and the patient haven't had any problems until then.To treat this, a revision surgery may need to be scheduled.

Event Description

It was reported that, ten years after a right thr done in (b)(6) 2012, where a ceramic insert standard 44/36 was implanted, the patient started noticing a creaking sound from their hip ((b)(6) 2022).After prolonged stress, pain then also occurred in the right hip.No trauma is remembered.The patient had been satisfied with the prosthesis until then.A revision surgery was done on (b)(6) 2023 to address this adverse event.The head and liner were replaced because of breakage of the ceramic insert standard 44/36.

Manufacturer Narrative

Additional information: results of investigation: it was reported that, ten years after a right total hip replacement, where a ceramic ceramic insert standard 44/36 was implanted, the patient started noticing a creaking sound from their hip.After prolonged stress, pain then also occurred in the right hip.No trauma is remembered, and the patient haven't had any problems until then.To treat this, a revision surgery was done, because of breakage of the ceramic insert.The complaint device used in treatment has not been completely returned as some fragments were not returned.A visual evaluation of the returned parts were conducted, and it was concluded that ceramic insert is fractured in more than 10 fragments of different size.The ball head was also returned for investigation, and it shows slight signs of use, however, the part is not fractured.The following investigation tasks have been performed for the complaint device: a review of the production documentation did not detect any deviation that could have contributed to the reported failure mode.There is no indication that the reported insert failed to meet manufacturing specifications upon release for distribution.The complaint history review for the complaint device revealed no additional complaints for the affected batch nor additional complaints for the same product number over the past 12 months with similar failure mode.A benefit risk analysis has been previously performed.The risks associated with the device, including potential undesirable adverse effects constitute acceptable risks when weighed against the benefits to the patient.A review of the risk management documentation verifies the failure mode, occurrence and severity of the reported issue.The instructions for use (lit.No.12.23, ed.03/21) states "audible noise" and "implant component fracture" as ¿potential medical device problems¿ and "pain" as a "potential adverse device effect" resulting from a hip arthroplasty.Further, the complaint samples were forwarded to the supplier for further investigation.Upon investigation of the supplier, the returned femoral head was not initially delivered to smith & nephew.Additionally, the before-mentioned instructions for use states that implants and implant components of smith & nephew orthopaedics ag must not be combined with other manufacturer implants, unless the implant combination is listed in the relevant surgical technique or in the compatibility matrix (lit.No.04758) available on www.Smith-nephew.Com/key-products/orthopaedic-reconstruction/.The supplier investigation highlights also, that the mix and match of components from different manufacturers of implant systems are not permitted for their devices (even if both were ultimately manufactured from the same supplier).The density of the insert was analysed and found to comply with its delivery specification.The microstructure as obtained from the respective quality documents meets the requirements at the time of production as well.There is no indication of any pre-existing material defects.Secondary metal transfer patterns can be located on the fragment of the insert and on the femoral head because of contact with metal parts and/or surgical instruments.Stripe wear on the polished surface of the femoral head and on the inner sphere of a fragment of the insert indicates an edge-loading situation and/or recurring subluxations.Some metal transfer particles were found in the outer surface of the insert, which indicates a disturbed or insufficient fixation of the insert in the metallic cup, which can lead to an increase of mechanical stress.Due to missing fragments and some fragments being chafed against each other, the primary fracture surface and the fracture origin cannot be detected.No conclusion can be drawn regarding a possible cause for the fracture of the insert based on the provided fragments.No clinically sufficient data was provided to perform a through medical investigation.The root cause of the reported fracture remains undetermined and due to insufficient information, it is not possible to speculate about contributing factors.However, an off-label use was identified.The root cause of this off-label use can be traced to the user by not following the instructions of the respective documents.By not following the instructions, all liability is excluded for the unauthorised use of third-party products.The need for further actions is not indicated.Nevertheless, smith+nephew will continue to monitor these devices for similar issues.The returned devices will be retained.Corrected data: b1 (type of event), b3 (occurrence date), b5 (narrative), d4 (lot number), d9,h3 (returned to manufacturer), e4 (reporter did not submit report to fda), h6 (health effect - clinical code, health effect - impact code, medical device problem code).

• Brand Name: CERAMIC CERAMIC INSERT STANDARD 44/36
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau CH-50 00; SZ CH-5000
• Manufacturer (Section G): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau CH-50 00; SZ CH-5000
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 16792412
• MDR Text Key: 313800899
• Report Number: 9613369-2023-00140
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 07611996074642
• UDI-Public: 7611996074642
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2018
• Device Catalogue Number: 75007454
• Device Lot Number: C1137366
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: PN: 3839717591500 / LOT: 7010700615
• Patient Outcome(s): Other
• Patient Age: 56 YR
• Patient Sex: Male