MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 3 HOLE ACET SHELL 60MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

Catalog Number 71335560

Device Problems Degraded (1153); Biocompatibility (2886); Device Dislodged or Dislocated (2923)

Patient Problems Joint Dislocation (2374); Metal Related Pathology (4530); Solid Tumour (4552)

Event Date 09/09/2013

Event Type  Injury  

Manufacturer Narrative

Internal reference number: (b)(4).H10: smith & nephew is submitting this report pursuant to the provisions of 21 c.F.R.Part 803.This report may be based upon information which smith & nephew has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, smith & nephew, or its employees, that the report constitutes an admission that the device, smith & nephew or its employees caused or contributed to the potential event described in this report.

Event Description

It was reported, after a left tha procedure was performed on the (b)(6) 2011, the patient experienced a dislocation, and a ct scan workup showed a large pseudotumor.A revision surgery was performed on the (b)(6) 2013 to treat this adverse event.During the revision surgery, a large metallosis area was found and the top surface of the acetabular cup was worn away.The patient supported the procedure and was taken to the recovery room.

Manufacturer Narrative

The reported event was analyzed.Although the involvement of all the devices was reported, the relationship with the investigated failure was directly associated to the r3 3 hole acet shell 60mm, the bhr modular head 54mm and the modular sleeve +4mm 12/14.Therefore, no investigation is deemed for the other devices.The devices were not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that, with the information provided the clinical root cause of the reported dislocation and metallosis cannot be definitively confirmed.It cannot be concluded the reported metallosis was associated with a mal performance of the implant or implant failure.The patient impact beyond the reported events cannot be determined with the available information.No further clinical assessment is warranted at this time.A review of the production orders did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history for the part numbers over the past 12 months and for the batch numbers based on historical data of the devices did not reveal similar events for the listed devices.For the shell, a review of the instructions for use documents for total hip systems revealed in the adverse events in primary and revision surgery section that although rare, metal sensitivity reactions and/or allergic reactions to foreign materials have been reported in patients following joint replacement, which have required device removal.Also, revealed that wear of the polyethylene, metal and ceramic articulating surfaces of acetabular components may occur as an adverse event.Higher rates of wear may be initiated by the presence of particles of cement, metal, or other debris which can develop during or as a result of the surgical procedure and cause abrasion of the articulating surfaces.For the head, a review of the instruction for use documents for birmingham hip¿ resurfacing (bhr¿) system revealed dislocation or subluxation leading to post-operative joint instability (which may be caused by malpositioning of the implants, or muscle or fibrous tissue laxity) as a potential adverse effect.For the sleeve, a review of the instruction for use documents for endoprostheses systems revealed in adverse effects that, although rare, metal sensitivity reactions and/or allergic reactions to foreign materials can occur.A review of the risk management files revealed this failure mode was previously identified.For the modular head, prior applicable escalation actions were identified, and confirmed to reduce associated risks.The bhr modular femoral head was phased out in mid-2014 for commercial reasons.The data of a prospective clinical study indicated a potential increased risk of fretting corrosion and accelerated release of metal debris at the taper junctions.Based on its analysis of this information, smith and nephew considers that patients implanted with said device may be at greater risk of revision surgery.For this reason, out of an abundance of caution, the company decided to issue an advisory notice to customers.No further escalation actions are required for the modular femoral head.For the sleeve and the shell, a historical review concluded that there are no prior actions related to these products and event.At this time, we have no evidence to suspect that the products failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include implant corrosion, irregular implant interaction, abnormal motion over time, patient condition, friction, joint tightness, traumatic injury or patient anatomy.Based on this investigation, the need for corrective action is not indicated.Should the devices 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.

• Brand Name: R3 3 HOLE ACET SHELL 60MM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS
• 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: 17650836
• MDR Text Key: 322287142
• Report Number: 1020279-2023-01681
• Device Sequence Number: 1
• Product Code: MBL
• UDI-Device Identifier: 03596010598288
• UDI-Public: 03596010598288
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K211176
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Consumer,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/06/2018
• Device Catalogue Number: 71335560
• Device Lot Number: 08BM07284
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/19/2023
• Date Device Manufactured: 02/09/2008
• 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: 71332520/REF SPHER HEAD SCREW 20MM.; 71332530/REF SPHER HEAD SCREW 30MM.; 71336500/REF THREADED HOLE COVER.; 74222154/BHR MODULAR HEAD 54MM.; 74222300/MODULAR SLEEVE +4MM 12/14.
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR
• Patient Sex: Male