MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG TRIAL FEMORAL HEAD 36 S/+0; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Model Number 75100856

Device Problems Component Missing (2306); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unequal Limb Length (4534); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/11/2022

Event Type  Injury  

Event Description

It was reported that, during thr surgery, a trial head lat.32 m /+4 was missing from a s&n loan instrument set, it was told that the current smith and nephew trial heads could be used as a replacement however they gave a false leg length whilst trialing this meant it was implanted the 36 +0 definitive ceramic head that the physician was happy with after the trial.The definitive femoral head however wasn't the same in offset and leg length as was trialed, this meant then had to remove the head (possibly loosening the stem in the process + potentially fracturing the ceramic head causing more damage) and re trial with the available nanos trial heads.This ended up being a 36 l (+8) femoral head which was implanted.The physician wasn¿t happy with this as it may have implications for the young patient.This once again highlights the issues is face working with loan kits that ship short of required instruments.The procedure was completed using a s+n back-up device.Surgery was greater than 30mins delayed.Patient was not harmed.No further information is available.

Manufacturer Narrative

Internal complaint reference: (b)(4).

Manufacturer Narrative

H3, h6: given the nature of the alleged incident, the associated device was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, this case reports, during a thr surgery, smith and nephew trial heads were used, in place of the missing nanos trial heads.It was reported that the physician was happy after the trial, and he implanted the 36 +0 definitive ceramic head, after implantation.The definitive femoral head wasn't the same in offset and leg length as was trailed.This meant the ceramic head had to be removed.The patient was re-trailed with the available nanos trial head which ended up being a 36 l (+8).The definitive 36 l (+8) femoral head was implanted.The patient¿s current health status is unknown.No clinical/medical records have been provided.Based on the information provided, the clinical root cause of the reported ¿false leg length,¿ and subsequent revision were related to the usage of the smith and nephew trial head in place the nanos trial head where the desired trial was not available in the instrument tray initially.It cannot be concluded that the reported event was related to a malperformance of the implant.The patient impact beyond the revision cannot be determined.A review of complaint history for the previous 12 months did not reveal similar events for the listed device.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.A historical review concluded that there are no prior actions related to this product and event.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.This device is a reusable instrument that can be exposed to numerous surgeries.Component loss during cleaning or handling is a likely probable causes of the reported event.Additionally, we recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.The contribution of the device to the reported event could not be corroborated.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.Should the device or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

Manufacturer Narrative

Corrected data: b1, b5, d1, d2, d3, d4, e1, g1, h6(health effect - clinical code, health effect - impact code, medical device problem code).

Event Description

It was reported that, during thr surgery, a trial femoral head was missing from a s&n loan instrument set.It was told that the current smith and nephew trial heads could be used as a replacement.However, trial femoral head 36 s/+0 gave a false leg length whilst trialing, this meant it was implanted the 36 +0 definitive ceramic head that the physician was happy with after the trial.The definitive femoral head however was not the same in offset and leg length as was trialed, this meant then had to remove the head (possibly loosening the stem in the process and potentially fracturing the ceramic head causing more damage) and re trial with the available nanos trial heads.This ended up being a 36 l (+8) femoral head which was implanted.The physician was not happy with this as it may have implications for the young patient.The procedure was concluded after a significant delay greater than 30 minutes, using a s+n back-up device.Patient was not harmed beyond the reported incident.

Manufacturer Narrative

H10: given the nature of the alleged incident, the device used in treatment was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, this case reports, during a total hip replacement (thr) surgery, smith and nephew trial heads were used, in place of the missing nanos trial heads.It was reported that the physician was happy after the trial, and he implanted the 36 +0 definitive ceramic head, after implantation.The definitive femoral head wasn't the same in offset and leg length as was trialed.This meant the ceramic head had to be removed.The patient was re-trialed with the available nanos trial head which ended up being a 36 l (+8).The definitive 36 l (+8) femoral head was implanted.The patient¿s current health status is unknown.No clinical/medical records have been provided.Based on the information provided, the clinical root cause of the reported ¿false leg length,¿ and subsequent revision were related to the usage of the smith and nephew trial head in place the nanos trial head where the desired trial was not available in the instrument tray initially.It cannot be concluded that the reported event was related to a malperformance of the implant.The patient impact beyond the revision cannot be determined.A complaint history review was performed.The occurrence of the reported failure mode is within its expected risk level as per risk management.The batch number of this device was not communicated and a review of the batch record could not be conducted.A review of past corrective actions was performed.No further escalation is required.Furthermore, a review of the risk management documentation was performed.The review verifies the failure mode and severity of the reported issue.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.This device is a reusable instrument that can be exposed to numerous surgeries.Component loss during cleaning or handling is a likely probable causes of the reported event.According to document "processing (cleaning, disinfection and sterilization) of instruments from smith & nephew orthopaedics ag", all instruments must be inspected and controlled for proper functioning after cleaning/disinfection.The contribution of the device to the reported event could not be confirmed.Based on this investigation, the need for corrective action is not indicated.The root cause stays undetermined.Nevertheless, smith + nephew will continue to monitor this device for similar issues.This complaint will be reopened should additional information or the device be received.Internal complaint reference number: (b)(4).

• Brand Name: TRIAL FEMORAL HEAD 36 S/+0
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau TN CH-50 00; SZ CH-5000
• Manufacturer (Section G): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau TN CH-50 00; SZ CH-5000
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 13996277
• MDR Text Key: 288501383
• Report Number: 1020279-2022-01487
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 07611996121896
• UDI-Public: 07611996121896
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K132435
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/29/2022

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
• Device Operator: Health Professional
• Device Model Number: 75100856
• Device Catalogue Number: 75100856
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/11/2022
• Initial Date FDA Received: 04/04/2022
• Supplement Dates Manufacturer Received: 04/26/2022; 06/29/2022; 08/24/2022
• Supplement Dates FDA Received: 05/24/2022; 07/11/2022; 08/29/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention