MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG POLARSTEM STEM LAT.TI/HA 7 NON-CEM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED

Catalog Number 75100480

Device Problem Fracture (1260)

Patient Problems Ossification (1428); Fall (1848); Failure of Implant (1924); Loss of Range of Motion (2032); Arthralgia (2355)

Event Date 06/20/2022

Event Type  Injury  

Manufacturer Narrative

H10: internal complaint reference: case (b)(4).

Event Description

It was reported that, after a tha of the right hip on (b)(6) 2017, the patient experienced their hip giving out, pain, and subsequently fell to the ground.The x-rays showed a fracture at the trunnion of the femoral stem.This condition was treated by performing a revision surgery of the right hip on (b)(6) 2022, during which the femoral stem and the femoral head were explanted and replaced with a smith and nephew high-offset femoral stem, an oxinium femoral head and four sets of accord cables and clamps.This revision surgery was significantly more complex and required more time, due to the fully ha coated (fractured) femoral stem, which was very difficult to remove.It took more than 2 hours remove the stem.The stem removal required an extended trochanteric osteotomy, which is an additional procedure, and then the osteotomy required fixation.The surgeon stated that this will lead to extended recovery and increased risk for complications post-operatively.The patient was transported to the recovery room in comfortable and stable condition.

Event Description

It was reported that, after a tha of the right hip on (b)(6) 2017, the patient experienced an heterotopic bone formation on their right hip.To resolve this issue, the ossification was excised on (b)(6) 2021.During this surgery, once the bone was removed around the prosthesis, it was noted that the acetabular component was stable.The femoral component was stable.There was no wear of the polyethylene.Despite the best efforts to create no damage in the femoral head, there were a couple small scratches from the osteotome in a non-weight bearing area near the trunnion on the femoral ball.This was found to be in a satisfactory location and there was no chance of wear.Furthermore, on (b)(6) 2022, the patient experienced their hip giving out, pain, and subsequently fell to the ground.The x-rays showed a fracture at the trunnion of the femoral stem.This condition was treated by performing a revision surgery of the right hip on (b)(6) 2022, during which the femoral stem and the femoral head were explanted and replaced with a smith and nephew high-offset femoral stem, an oxinium femoral head and four sets of accord cables and clamps.This revision surgery was significantly more complex and required more time, due to the fully ha coated (fractured) femoral stem, which was very difficult to remove.It took more than 2 hours remove the stem.The stem removal required an extended trochanteric osteotomy, which is an additional procedure, and then the osteotomy required fixation.The surgeon stated that this will lead to extended recovery and increased risk for complications post-operatively.The patient was transported to the recovery room in comfortable and stable condition.

Manufacturer Narrative

H3, h6: it was reported that, after a tha of the right hip on (b)(6) 2017, the patient experienced their hip giving out, pain, and subsequently fell to the ground.The x-rays showed a fracture at the trunnion of the femoral stem.This condition was treated by performing a revision surgery of the right hip on (b)(6) 2022, during which the femoral stem and the femoral head were explanted and replaced with a smith and nephew high-offset femoral stem, an oxinium femoral head and four sets of accord cables and clamps.This revision surgery was significantly more complex and required more time, due to the fully ha coated (fractured) femoral stem, which was very difficult to remove.It took more than 2 hours remove the stem.The stem removal required an extended trochanteric osteotomy, which is an additional procedure, and then the osteotomy required fixation.The surgeon stated that this will lead to extended recovery and increased risk for complications post-operatively.The patient was transported to the recovery room in comfortable and stable condition.The complaint device used 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 over the past 12 months with similar failure mode.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 (lit.No.12.23, ed.07/10) states "fracture of the implant, bone or cement" as a ¿possible side effect¿ in combination with the implantation of a hip prosthesis.Avoid implant contact with materials that might damage the implant surface.It is important to check the implant before it is inserted to ensure it is not damaged.The received medical documentation was reviewed.Heterotopic ossification is a known complication of joint surgeries, some patients can be genetically predisposed, it is related to the procedure and not the device.It is unknown if the fall or the femoral neck fracture occurred first.The reported damage to the femoral component in the form of ¿a couple small scratches from the osteotome in a non-weightbearing area near the trunnion on the femoral ball¿ is a possible contributing factor to the femoral neck fracture, and subsequent revision.We don¿t have information if there was impingement and can¿t rule out micromotion.The patient impact is the reported fall, extended trochanteric osteotomy, revision, and extended post-op recovery period.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.Specific factors known to contribute to the alleged fault are excessive physical activity levels, unreasonable stress on replacement system, excessive patient weight and trauma to the joint replacement, there is no need for further actions.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.Corrected data: h6 (health effect - clinical code, health effect - impact code).

• Brand Name: POLARSTEM STEM LAT.TI/HA 7 NON-CEM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED
• 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: 18204431
• MDR Text Key: 328896141
• Report Number: 9613369-2023-00218
• Device Sequence Number: 1
• Product Code: LWJ
• UDI-Device Identifier: 07611996118711
• UDI-Public: 07611996118711
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130728
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/10/2023
• Device Catalogue Number: 75100480
• Device Lot Number: B1612184
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/15/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/11/2016
• 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: **SEVERAL CONCOMITANT MEDICAL PRODUCTS TO BE FOUND; 71332756/16LM12993/R3 0 DEG XLPE ACET LNR 36MM X M; 71335556/17AW01043/R3 3 HOLE ACET SHELL 56MM; 71336500/16MM12841/REF THREADED HOLE COVER; 71343608/16DM14640A/OXINIUM FEM HD 12/14 36 MM L/+
• Patient Outcome(s): Required Intervention; Hospitalization; Other
• Patient Age: 76 YR
• Patient Sex: Male
• Patient Weight: 131 KG