MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKN R3 SHELL; PROSTHESIS, HIP, SEMI-CONS, UNCEMENTED, METAL/POLY, POROUS

Catalog Number UNKNOWN

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

Patient Problem Unspecified Infection (1930)

Event Date 07/15/2022

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: (b)(6).

Event Description

It was reported that, on a clinical activity report "long-term clinical outcome study of the polarstem collared and valgus ¿ a retrospective-prospective 2-10 year follow up study", one (1) patient suffered from a prosthetic joint infection after having a primary r3-tha surgery with an oxinium femoral head and a collared polarstem.This patient underwent a reoperation for a girdlestone procedure.All the system was explanted.The outcome of the patient is unknown.No further information is available.

Manufacturer Narrative

H10: additional information in a2, a3 and b7.

Manufacturer Narrative

H3, h6: the device was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, this case reports, a clinical study ("long-term clinical outcome study of the polarstem collared and valgus ¿ a retrospective-prospective 2-10 year follow up study,") and the patient experienced an unspecified prosthetic joint infection 1 year post primary total hip arthroplasty surgery.Reportedly, the explantation of the implants, and a subsequent girdle stone procedure was performed to treat the adverse event.Per case details, it has been communicated that no further information is available.Without the patient specific clinically relevant supporting documentation, the root cause of the reported ¿prosthetic joint infection,¿ cannot be definitively concluded and the patient impact beyond the reported prosthetic joint infection and revision cannot be determined.The patient¿s current health status is unknown.Therefore, no further clinical medical assessment can be rendered.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 are not limited to loss of sterility, contamination, patient reaction, and post-operative healing issue.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.Internal complaint reference number: (b)(4).

• Brand Name: UNKN R3 SHELL
• Type of Device: PROSTHESIS, HIP, SEMI-CONS, UNCEMENTED, METAL/POLY, POROUS
• Manufacturer (Section D): SMITH & NEPHEW, INC.; brooks road; 1450; memphis TN 38116
• 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: 15142300
• MDR Text Key: 297032572
• Report Number: 9613369-2022-00465
• Device Sequence Number: 1
• Product Code: MBL
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 09/26/2022

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/15/2022
• Initial Date FDA Received: 08/01/2022
• Supplement Dates Manufacturer Received: 09/01/2022; 09/16/2022
• Supplement Dates FDA Received: 09/12/2022; 09/27/2022
• Was Device Evaluated by Manufacturer?: No
• 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: UNKNOWN FEMORAL HEAD MEMPHIS OXINIUM; UNKNOWN POLARSTEM CEMENTLESS (TI/HA); UNKNOWN R3 LINER CERAMIC POLY; UNKNOWN R3 SHELL
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 49 YR
• Patient Sex: Male