MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 3 HOLE ACET SHELL 52MM; PROST, HIP, SEMI-CNSTRND, MET/CER/CER/MET, CMNTD OR UNCMNTD

Catalog Number 71335552

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fall (1848); Pain (1994); Loss of Range of Motion (2032); Discomfort (2330); Swelling/ Edema (4577)

Event Date 01/02/2019

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference number: (b)(4).

Event Description

*us legal* it was reported that patient hasn¿t undergo a medically-indicated revision of the system right hip implant yet, but the patient is complaining to have experiences of pain, discomfort, hip motion difficulties in her right hips as well as associated pain and discomfort.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

The device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, the provided medical records were reviewed.However, they do not aid in the clinical investigation as they precede the reported events.Therefore, based on insufficient information, no further medical assessment cannot be performed at this time.Should any additional relevant clinical information be provided, this complaint would be re-assessed.Should clinically relevant documentation/ information and/or relevant product evaluation results become available, the clinical/medical task may be re-evaluated.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Possible causes could include but not limited to traumatic injury, joint tightness, material in use, patient reaction, loss of sterility, alignment, fit/size of device used or wear.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

Patient's age added.

Event Description

T was reported that patient hasn¿t undergo a medically-indicated revision of the r3 system right hip implant yet, but the patient is complaining to have experiences of pain, discomfort, hip motion difficulties in her right hips as well as associated pain and discomfort.The patient has had several lidocaine injections due to trochanteric bursitis.The issue is still unresolved.

Manufacturer Narrative

Internal reference number: (b)(4).

Manufacturer Narrative

Manufacture date added the device was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, based on the information provided, the clinical root cause of the reported pain, swelling, popping and locking up of her left hip cannot be determined.However, the patient¿s diagnosis of greater trochanteric bursitis is most likely a cause of the reported pain.It cannot be concluded that the reported events are associated with a malperformance of the implant.The impact to the patient beyond that which has already been reported cannot be determined.No further clinical assessment is warranted at this time.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history revealed similar events for the listed device over the previous 18 months, but no similar events for the batch based on the historical data, this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the instructions for use documents for total hip systems revealed that a decreased range of motion has been identified as a potential complication.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.Possible causes could include but not limited to traumatic injury, joint tightness, material in use, patient reaction, loss of sterility, alignment, fit/size of device used or wear.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.Case (b)(4).

Manufacturer Narrative

H6: health effect - clinical code and health effect - impact code.H7: if remedial action initiated, check type, h9: if action reported to fda under 21 usc 360i(f), list correction/removal reporting number.Section h3, h6: the device was not returned for evaluation, however the reported adverse event could be confirmed since the batch number is part of recall r-2020-04.The clinical/medical investigation confirmed through the x-ray reports that the implants were in satisfactory alignment, and concluded that, based on the information provided, the clinical root cause of the reported pain, swelling, popping and locking up of her left hip cannot be determined.However, the patient¿s diagnosis of greater trochanteric bursitis is most likely a cause of the reported pain.It cannot be concluded that the reported events are associated with a malperformance of the implant.The impact to the patient beyond that which has already been reported cannot be determined.No further clinical assessment is warranted at this time.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history revealed similar events for the listed device over the previous 18 months, but no similar events for the batch based on the historical data, this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the instructions for use documents for total hip systems revealed that a decreased range of motion has been identified as a potential complication.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.At this time, we do have reason to suspect that the product failed to meet product specifications at the time of manufacture.Manufacturing process errors could be the probable cause for the recall action.Probable cause for the pain and dissatisfaction could be related to traumatic injury, joint tightness, patient reaction or postoperative care.The primary surgery was performed before the recall take action.The contribution of the device to the reported event could be corroborated since the device was part of recall r-2020-04.Based on this investigation, the need for corrective action is indicated.A historical review concluded that this event was previously identified and addressed through a retrain program on how to read cmm reports, the installation of color printers on all cmms across memphis, implementation of quality review of cmm reports, the creation of work instruction for recording and reviewing variable data, revision of work instructions and the creation of training checklists.In addition, this event was addressed through a market removal of the product.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.

• Brand Name: R3 3 HOLE ACET SHELL 52MM
• Type of Device: PROST, HIP, SEMI-CNSTRND, MET/CER/CER/MET, CMNTD OR UNCMNTD
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 11383291
• MDR Text Key: 233716309
• Report Number: 1020279-2021-01611
• Device Sequence Number: 1
• Product Code: MRA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer,Company Representative
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 09/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 71335552
• Device Lot Number: 18JM17689A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/25/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-2331-2020
• Patient Sequence Number: 1
• Treatment: 71335752 / R3 20 DEG XLPE ACET LNR 36MM X 52MM; 71343603 / OXINIUM FEM HD 12/14 36 MM -3; 75100463 / POLARSTEM STEM STD TI/HA 0 NON-CEM; UNKN FEM HEAD MEMPHIS OX; UNKN FEM HEAD MEMPHIS SLEEVE; UNKN ORTHOPAEDIC RECONSTRUCTION DEV; UNKN R3 CERAMIC LINER; UNKN CERAMIC LINER; UNKN FEM HEAD MEMPHIS OX; UNKN FEM HEAD MEMPHIS SLEEVE; UNKN ORTHOPAEDIC RECONSTRUCTION DEV
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 54 YR
• Patient Sex: Female