MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG POLARSTEM STEM STD TI/HA 1 NON-CEM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Model Number 75100464

Device Problem Off-Label Use (1494)

Patient Problems Arthralgia (2355); Joint Dislocation (2374)

Event Date 04/01/2023

Event Type  Injury  

Manufacturer Narrative

Complaint reference number: (b)(4).

Event Description

It was reported that, after a tha had been performed on (b)(6) 2022 with a ceramic-on-polyethylene polar3 system (with a ceramic head sourced from a different manufacturer), the patient has experienced three dislocations.On (b)(6) 2023, after 6-month post-op, the first dislocation occurred after the patient fell down the stairs, followed by other two dislocations, occurring on (b)(6) 2023 and (b)(6) 2023.Ct revealed that most likely there is significant soft tissue compromise in the abductors post fall downstairs.Ct scan also confirms anatomical positioning of acetabular and femoral components and no loosening of the implants.Each dislocation was addressed via close reduction.The patient is doing well and has travelled abroad to get a second opinion on hip.

Event Description

It was reported that, after a tha had been performed on (b)(6) 2022 with a ceramic-on-polyethylene polar3 system (with a ceramic head sourced from a different manufacturer), the patient has experienced three dislocations.On (b)(6) 2023, after 6-month post-op, the first dislocation occurred after the patient fell down the stairs, followed by other two dislocations, occurring on (b)(6) 2023 and (b)(6) 2023.Ct revealed that most likely there is significant soft tissue compromise in the abductors post fall downstairs.Ct scan also confirms anatomical positioning of acetabular and femoral components and no loosening of the implants.Each dislocation was addressed via close reduction.The patient is doing well and has travelled abroad to get a second opinion on hip.In that visit, two components were revised.

Manufacturer Narrative

H3, h6: it was reported that, after a total hip arthroplasty (tha) had been performed on (b)(6)2022 with a ceramic-on-polyethylene polar3 system (with a ceramic head sourced from a different manufacturer), the patient has experienced three dislocations.On (b)(6)2023, after 6-month post-op, the first dislocation occurred after the patient fell down the stairs, followed by other two dislocations, occurring on (b)(6) 2023 and (b)(6) 2023.Ct revealed that most likely there is significant soft tissue compromise in the abductors post fall downstairs.Ct scan also confirms anatomical positioning of acetabular and femoral components and no loosening of the implants.Each dislocation was addressed via close reduction.The patient is doing well and has travelled abroad to get a second opinion on hip.In that visit, two components were revised.The following investigation tasks have been conducted for the polarstem stem std ti/ha 1 non-cem (article n°75100464 and batch n°c2146301).The complaint article was not returned for investigation.Hence, no visual evaluation of the respective complaint device could be conducted.A review of the product documentation did not detect any deviation that could have contributed to the reported failure mode.A review of past corrective actions was performed.No further escalation is required.A review of the risk management documentation has been conducted.The occurence and severity are in line with the corresponding risk file.The review of historical complaints for the alleged device revealed no additional similar complaints reported for the same batch, and no additional similar complaints for the same product number over the past 12 months with similar failure mode.A review of the device labeling revealed that the current ifu (lit.No.12.23, ed.03/21) states joint dislocations and joint instability of the component as a ¿potential adverse device effect¿ in combination with the implantation of a hip prosthesis.Further, the before-mentioned ifu 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/.All liability is excluded for the unauthorised use of third-party products.Upon clinical evaluation, the provided x-ray and fluoroscopy were reviewed, but do not correspond with the reported event dates.Therefore, no relationship to the reported events can be confirmed.All documents and images provided as of this date have been reviewed and considered and unless noted do not contribute to the clinical investigation.Further, the implants should always be implanted using smith & nephew orthopaedics ag surgical instruments, unless these are commonly used in the operating room and/or described in the surgical technique.The first dislocation and closed reduction was noted to be after a fall down the stairs.The second and third dislocations and closed reductions were reported by the surgeon and post "exaggerated external rotation" episodes.It cannot be concluded the reported dislocations, closed reductions and subsequent revision were associated with a mal performance of the implant or implant failure.The patient impact beyond the reported events cannot be determined.No further clinical assessment is warranted at this time.Based on the available information, the complaint can be confirmed.An off-label use was identified.The root cause is 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.Smith & nephew will continue to monitor this device for similar issues.This investigation is considered closed.

• Brand Name: POLARSTEM STEM STD TI/HA 1 NON-CEM
• 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: 17114499
• MDR Text Key: 317048003
• Report Number: 9613369-2023-00157
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 07611996118551
• UDI-Public: 07611996118551
• Combination Product (y/n): N
• Reporter Country Code: PK
• PMA/PMN Number: K130728
• 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,Followup
• Report Date: 07/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 75100464
• Device Catalogue Number: 75100464
• Device Lot Number: C2146301
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/10/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/18/2021
• 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: 71332525 / LOT NUMBER 21MB00158; 71332530 / LOT NUMBER 21LB00551; 71335552 / LOT NUMBER 22AW09059; 71335752 / LOT NUMBER 21GM05716
• Patient Outcome(s): Required Intervention
• Patient Age: 26 YR
• Patient Sex: Female
• Patient Weight: 64 KG