MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG POLARSTEM COLLAR STD. TI/HA 3; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS,

Model Number	75018403
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Pain (1994)
Date of Event	05/18/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, two years after a revision surgery of hip had been performed, in which a s&n system was implanted, the patient started experiencing a deterioration in the state of health: extreme pain, difficulty for walking, weight loss, lethargia, and anaemia.Mobility is being assisted with walking sticks (indoors), elbow crutches (outdoors) and scooter (long distances).The pain is being managed by taking morphine, paracetamol and codeine.Although x-rays, mri scans, nuclear bone scan have been performed, nothing totally conclusive has been spotted.The patient is requesting a revision of hip.The event is ongoing.
Additional Manufacturer Narrative
Additional information: b5 and g4.
Event or Problem Description
It was reported that, two years after a revision surgery of hip had been performed, in which a s&n system was implanted, the patient started experiencing a deterioration in the state of health: extreme pain, difficulty for walking, weight loss, lethargia, and anaemia.Mobility is being assisted with walking sticks (indoors), elbow crutches (outdoors) and scooter (long distances).The pain is being managed by taking morphine, paracetamol and codeine.Although x-rays, mri scans, nuclear bone scan have been performed, nothing totally conclusive was spotted.A revision surgery was performed by the end of (b)(6) 2020 and doctor planned to remove ball head but it was noted that the r3 was loose and worn out.
Additional Manufacturer Narrative
Additional info: results of investigation: it was reported that, two years after a revision surgery, in which a s+n system was implanted, the patient started experiencing a deterioration in the state of health: extreme pain, difficulty to walk, weight loss, lethargy and anemia.X-rays and mri scans were inconclusive, the patient is requesting a revision of the hip.The implanted polarstem collar, (b)(6) used in treatment, was not returned for investigation as it is still implanted.A batch record review was performed, no deviations regarding the performance of the device could be found.No further complaint for the batch in scope was registered.The failure mode is covered through our risk management files.According to the ifu 12.23 ed.05/16 pain is a possible side effect.The combination of the implanted stem and ball head ((b)(6)) is approved by smith and nephew (lit.No.04758).As no further medical information was received, a medical assessment could not be conducted.Due to insufficient information the failure mode cannot be confirmed and the root cause stays undetermined after investigation.To date, the need for further actions is not indicated.Should additional information become available, this complaint will be reassessed.Smith and nephew will monitor this device for further similar issues.
Additional Manufacturer Narrative
Updated results of investigation: it was reported that, two years after a revision surgery, in which a smith and nephew system was implanted, the patient started experiencing a deterioration in the state of health: extreme pain, difficulty to walk, weight loss, lethargy and anemia.The implanted polarstem collar, 75018403, used in treatment, was not returned for investigation as it is still implanted.A batch record review was performed, no deviations regarding the performance of the device could be found.No further complaint for the batch in scope was registered.The failure mode is covered through the risk management files of smith and nephew.According to the ifu (b)(4), valid to the time of performed revision surgery, pain is a possible side effect in combination with the implantation of a hip prosthesis.The combination of the implanted stem and ball head (71303204) is approved by smith and nephew (lit.No.04758).Upon medical investigation, the patient states that he started experiencing a deterioration in the state of health: extreme pain, difficulty for walking, weight loss, lethargy, and anemia.Mobility is being assisted with walking sticks (indoors), elbow crutches (outdoors) and scooter (long distances).The pain is being managed by taking morphine, paracetamol and codeine.According to medical investigation, even though x-rays, mri scans, nuclear bone scan have been performed and evaluated, nothing totally conclusive was spotted.The impact to this patient has been pain and loss of the ability to perform activities of daily living.In conclusion, the symptoms described by this patient, may be consistent with a reaction to metal debris.However, without medical documentation, it cannot be investigated.Further, it cannot be concluded that the reported clinical findings are associated with the implant failure.Due to insufficient information the failure mode cannot be confirmed and the root cause stays undetermined after investigation.To date, the need for further actions is not indicated.Should additional information become available, this complaint will be reassessed.Smith and nephew will monitor this device for further similar issues.This investigation is considered closed.
Additional Manufacturer Narrative
B4: description updated.D4: lot number, udi and expiration date updated.H4: manufactured date updated.
Event or Problem Description
It was reported that, after a left thr revision surgery had been performed on (b)(6) 2017 with extreme pain, difficulty for walking, weight loss, lethargia, and anaemia diagnosis, the patient experienced unexplained pain and adverse soft tissue reaction to particulate debris that made necessary a second revision surgery on (b)(6) 2020.According to the report contents, the acetabular cup, modular head, acetabular liner were explanted and replaced with smith and nephew devices.This information was provided by the national joint registry of the united kingdom, as part of a retrospective data collection of patients who underwent a first thr revision surgery with a hip prosthesis construct that included a polarstem femoral prosthesis and that required a second revision surgery due to specific reasons.As such, no further information will be available.
Event or Problem Description
It was reported that, after a left thr revision surgery had been performed on (b)(6) 2017, the patient experienced unexplained pain and adverse soft tissue reaction to particulate debris that made necessary a second revision surgery on (b)(6) 2020.According to the report contents, the acetabular cup, modular head, acetabular liner were explanted and replaced with smith and nephew devices.This information was provided by the national joint registry of the united kingdom, as part of a retrospective data collection of patients who underwent a first thr revision surgery with a hip prosthesis construct that included a polarstem femoral prosthesis and that required a second revision surgery due to specific reasons.As such, no further information will be available.
Additional Manufacturer Narrative
Additional information: h6 (health effect - impact code).Corrected data: a2 (age at time of event), b5 (narrative), h6 (health effect - clinical code, type of investigation).Updated results of investigation: according to data obtained from the national joint registry of the united kingdom, it was reported that, after a left total hip replacement revision surgery had been performed on (b)(6) 2017, the patient experienced unexplained pain and adverse soft tissue reaction to particulate debris that made necessary a second revision surgery on (b)(6) 2020.According to the report contents, the acetabular cup, modular head, acetabular liner were explanted and replaced with smith and nephew devices.The device intended for use in treatment was not returned for investigation.A product evaluation was not possible.A review of the production documentation did not detect any deviation that could have contributed to the reported failure mode.The complaint history review for the complaint device revealed no additional complaints for the affected batch, nor additional complaints for the same product number within the last 12 months from the initial reporting date.A review of past corrective actions was performed.No further escalation is required.A review of the risk management documentation verifies the failure mode, occurrence and severity of the reported issue.The instructions for use (12.23 ed.05/16, valid to the time of performed revision surgery) consider that pain is a possible side effect in combination with the implantation of a hip prosthesis.The combination of the implanted stem and ball head (b)(6) is approved by smith and nephew (lit.No.(b)(6)).The requested supporting clinical documentation has not been provided; therefore, there were no clinical factors found which would have contributed to the reported events/clinical reactions.With the limited information provided, the patient impact beyond the reported revision cannot be determined.The performed investigation does not lead to an accurately determined cause.There is no evidence that the reported devices failed to meet manufacturing specifications upon release for distribution.Due to insufficient information, it is not possible to indicate factors which could have contributed to the reported event.There is no need for further actions because of the limited information provided.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.

• Brand Name: POLARSTEM COLLAR STD. TI/HA 3
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS,
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau ; SZ
• Manufacturer (Section G): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau ; SZ
• Manufacturer Contact: sarah freestone ; oberneuhofstrasse 10d; baar ; SZ ; 0447940038
• MDR Report Key: 10081205
• Report Number: 9613369-2020-00092
• Device Sequence Number: 2835398
• Product Code: MEH
• UDI-Device Identifier: 07611996103403
• UDI-Public: 07611996103403
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K143739
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 08/29/2023

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/17/2023
• Device Model Number: 75018403
• Device Catalogue Number: 75018403
• Device Lot Number: B1617541
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 04/26/2020
• Supplement Date Received by Manufacturer: 04/26/2020; 07/23/2020; 03/18/2021; 02/03/2023; 08/24/2023
• Initial Report FDA Received Date: 05/21/2020
• Supplement Report FDA Received Date: 08/06/2020; 08/13/2020; 04/09/2021; 02/03/2023; 08/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/18/2016
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 72 YR
• Patient Sex: Male