MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REF LNR 32X 54-56 20 DG SZ F; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number 71743254

Device Problems Material Erosion (1214); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Failure of Implant (1924)

Event Date 02/07/2024

Event Type  Injury  

Event Description

It was reported that, after a thr had been performed on (b)(6) 2013, the patient experienced wearing of the insert.A revision surgery was performed on (b)(6) 2024 to exchange the insert and ball head.The surgery was successfully completed.

Manufacturer Narrative

H10: internal complaint reference: (b)(4).

Event Description

It was reported that, after a thr had been performed on (b)(6) 2013, the patient required a revision due to wear of the insert.A revision surgery was performed on (b)(6) 2024 to exchange the insert and ball head.The surgery was successfully completed.

Manufacturer Narrative

Additional information: h6 (component code, type of investigation, investigation findings, investigation conclusions).Results of investigation: the associated devices were returned and evaluated.The visual inspection revealed that the ceramic head shows scratches and black marks on the surface.A visual inspection of the returned acetabular liner revealed scratches and gouges and the returned porous acetabular shell reveals discoloration, scratches and gouges.This inspection was conducted using a magnifying glass.A review made by the quality engineering team was conducted by placing the femoral head into the acetabular liner and visually inspecting the fit between the mating components.A secure fit was unable to be achieved between the femoral head and acetabular liner demonstrating wear of the acetabular liner.The maximum gap observed was of 3.04 mm over the life of the implant.There were no material and manufacturing issues of note during the investigation.The clinical/medical investigation concluded that the provided images do not provide insight into a clinical root cause for the reported wear.The patient impact is the worn liner, revision and 50-minute surgical delay.A review of the production order did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history for the part number over the past 12 months and for the batch number based on historical data of the device did not reveal similar events for the listed device.A review of the instructions for use documents for total hip systems 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.A review of the risk management file 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 this product and event.At this time, we have no evidence to conclude that the product failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include friction or joint tightness.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.Corrected data: b5 (narrative), d9&h3 (sample returned for analysis), h6 (medical device problem code).

• Brand Name: REF LNR 32X 54-56 20 DG SZ F
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• 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: 18816352
• MDR Text Key: 336660459
• Report Number: 1020279-2024-00461
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 03596010232335
• UDI-Public: 03596010232335
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K932755
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/23/2024

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 Operator: Health Professional
• Device Expiration Date: 07/31/2022
• Device Catalogue Number: 71743254
• Device Lot Number: 12GM16411
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/08/2024
• Initial Date FDA Received: 03/01/2024
• Supplement Dates Manufacturer Received: 04/19/2024
• Supplement Dates FDA Received: 04/23/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/31/2012
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other