MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 MULTI HOLE ACETABULAR SHELL 52MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

Model Number 71338665

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Failure of Implant (1924); Joint Laxity (4526)

Event Date 02/22/2023

Event Type  Injury  

Event Description

It was reported that, after thr surgery had been performed on (b)(6) 2016, the patient experienced a dislocation.This adverse event was solved by a revision surgery performed on (b)(6) 2023, in which one (1) anthology ho porous sz 8, one (1) oxinium fem hd 12/14 32mm +8, one (1) r3 20 deg xlpe acet lnr 32mm x 52mm and one (1) r3 multi hole acetabular shell 52mm were explanted.Patient status is unknown.

Manufacturer Narrative

Internal complaint reference: (b)(4).

Manufacturer Narrative

H3, h6.The devices were not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that, as of the date of this medical investigation, supporting clinical documentation has not been provided.The patient impact beyond the reported dislocation and subsequent revision cannot be determined.No further clinical/medical assessment is warranted at this time.Devices batch numbers were not provided, thus, an evaluation of the manufacturing records could not be performed.For r3 multi hole acetabular shell 52mm, ref spher head screw 15mm, oxinium fem hd 12/14 32mm +8 and r3 20 deg xlpe acet lnr 32mm x 52mm a review of complaint history of the previous 12 months revealed similar events for the listed devices, this failure mode will be monitored for future complaints for any necessary corrective actions.For anthology ho porous sz 8 a review of complaint history for the previous 12 months did not reveal similar events for the listed device.A review of the instructions for use documents for total hip systems reveals for postoperative warnings and precautions the need of warning patients against unassisted activity, particularly use of toilet facilities and other activities that require excessive motion of the hip, as they may result in subluxation or dislocation.A review of the risk management files revealed this failure mode was previously identified.The anticipated risk level is still adequate.A historical review concluded that there are no prior actions related to these products and event.At this time, we have no reason to suspect that the product failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include traumatic injury, patient anatomy or abnormal loading of limb.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 MULTI HOLE ACETABULAR SHELL 52MM
• 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: 16569580
• MDR Text Key: 311557309
• Report Number: 1020279-2023-00580
• Device Sequence Number: 1
• Product Code: MBL
• UDI-Device Identifier: 00885556021491
• UDI-Public: 00885556021491
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K092386
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 71338665
• Device Catalogue Number: 71338665
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/12/2023
• 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: A
• Patient Sequence Number: 1
• Treatment: 71332515 / UNK.; 71337652 / UNK.; 71343208 / UNK.; 71356108 / UNK.
• Patient Outcome(s): Required Intervention