MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ANTHOLOGY HIP IMPLANT; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/CERAMIC/METAL, CEMENTED OR UNCE

Catalog Number UNKNOWN

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

Patient Problems Unspecified Infection (1930); Infiltration into Tissue (1931); Metal Related Pathology (4530)

Event Date 11/01/2021

Event Type  Injury  

Event Description

It was reported that the plaintiff underwent a revision surgery on (b)(6) 2022 due to a left hip periprosthetic joint infection.The revision surgery consisted in: 1) the explantation of the bhr-tha system and placement of an articulating antibiotic spacer with acetabular and femoral components.2) irrigation and debridement procedure of the left hip skin, subcutaneous tissue, muscle, and bone.3) left hip proximal femur and extended trochanteric osteotomy.During the revision surgery, purulence was seen, as well as trunnion corrosion.The patient tolerated the procedure well.This patient had a previous left hip implant infection in (b)(6) 2021, which was treated with an irrigation and debridement procedure and iv antibiotic therapy.The primary left hip bhr tha procedure was performed on (b)(6) 2010.

Manufacturer Narrative

Internal complaint reference: (b)(4).

Manufacturer Narrative

Section h3, h6: the device was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, patient had a left tha (b)(6) 2010 and a left revision 11.5 years post implantation.The surgical indications for the revision were noted as recurrence of infection with a draining sinus.The initial infection was noted to have occurred (b)(6) 2021, at that time he was treated with irrigation and debridement¿s and was placed on iv antibiotics.Four months later he had a revision with explantation of implants and placement of articulating antibiotic spacer with acetabular and femoral components.The revision operative findings were, ¿a draining sinus over the left hip that tracked to the deep hip joint where purulence was seen, well-fixed components with bony ingrowth along the entire length of the femoral stem down to the tip, and deficiency of the posterior acetabular wall.Trunnion corrosion was seen; however, there did not appear to be significant adverse local tissue reaction.¿ post operative planning included ¿long-term iv antibiotics, likely 6-8 weeks, and additional oral antibiotic course.We will plan for second-stage reimplantation in the future once it appears that the infection has been eradicated.¿ no documents have been provided regarding the planned second stage of the revision.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 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.H6: health effect - clinical code and health effect - impact code.

• Brand Name: ANTHOLOGY HIP IMPLANT
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/CERAMIC/METAL, CEMENTED OR UNCE
• 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: 15124847
• MDR Text Key: 296842001
• Report Number: 1020279-2022-03520
• Device Sequence Number: 1
• Product Code: MRA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/30/2022

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/12/2022
• Initial Date FDA Received: 07/28/2022
• Supplement Dates Manufacturer Received: 08/26/2022
• Supplement Dates FDA Received: 08/30/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 BIRMINGHAM HIP MODULAR HEAD (BHMH) SLEEVE.
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 71 YR
• Patient Sex: Male