MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 CONST 56MM; PROSTHESIS, HIP, CONSTRAINED, CEMENTED OR UNCEMENTED, METAL/POLYMER

Catalog Number	71339156
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032); Joint Laxity (4526); Swelling/ Edema (4577)
Date of Event	04/18/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after a revision thr procedure was performed on (b)(6) 2024, the patient sat on arm of a couch and felt 2 pops in his hip.Since then the patient has experienced swelling and pain with ambulation or laying in certain positions.Also complaining of instability in his left hip.This adverse event was treated by a revision surgery on (b)(6) 2024, in which a r3 const 56mm and a oxinium fem hd 12/14 22 mm +8 were exchanged.Patient's current health status is unknown.
Additional Manufacturer Narrative
Internal reference number: case-(b)(4).
Additional Manufacturer Narrative
D10 has been updated.
Additional Manufacturer Narrative
H2: additional information ¿h6: health effect - clinical code¿ h3, h6: the associated devices were returned and evaluated.The visual inspection revealed damage to the outer profile of the liner, with scratches and gouges on the device.Also the metal ring is bent.The visual inspection of the returned femoral head revealed scratches and nicks to the outer profile.The clinical/medical investigation concluded that, without the supporting medical documentation, the root cause of the reported recurrent dislocations and revisions cannot be definitively concluded; however, the patient's body mass index, condition of surrounding/supportive soft-tissues in light of the multiple left hip interventions, and patient activity are likely contributing factors to the reported events.The patient impact is determined to be the reported instability/joint laxity after feeling the ¿2 pops¿ with swelling and pain along with the need for an assist device.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 device did not reveal similar events for the listed devices.A review of the instructions for use documents for total hip systems revealed in the postoperative warnings and precautions section that the patient should be advised to report any pain, decrease in range of motion, swelling, fever, squeaking, clicking, popping, grating, or grinding noises, and unusual incidences.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 evidence to conclude that the products failed to meet any specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.Should 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 CONST 56MM
• Common Device Name: PROSTHESIS, HIP, CONSTRAINED, CEMENTED OR UNCEMENTED, METAL/POLYMER
• 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: 19337330
• Report Number: 1020279-2024-00955
• Device Sequence Number: 11415073
• Product Code: KWZ
• UDI-Device Identifier: 00885556020470
• UDI-Public: 00885556020470
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K083566
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/20/2024

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 Catalogue Number: 71339156
• Device Lot Number: 23JM06977
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/18/2024
• Supplement Date Received by Manufacturer: Not provided; 08/16/2024
• Initial Report FDA Received Date: 05/16/2024
• Supplement Report FDA Received Date: 05/16/2024; 08/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/13/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: OXINIUM FEM HD 12/14 22 MM +8 / 71342208
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown
• Patient Weight: 166 KG