MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REF LNR 28X 58-60 20DG SZ G; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	71742858
Medical Device Problem Code	Material Erosion (1214)
Health Effect - Clinical Codes	Failure of Implant (1924); Osteolysis (2377); Joint Laxity (4526); Implant Pain (4561)
Date of Event	08/04/2010
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference:(b)(4).
Event or Problem Description
It was reported that, after a tha construct had been implanted on the patient¿s right hip on (b)(6) 2000 , the patient experienced painful hardware with hip instability.A complex revision surgery was performed on (b)(6) 2010.During this procedure, the acetabular components and the femoral head were explanted and replaced with an r3-tha construct.Intraoperatively, significant polyethylene wear with lysis was encountered.The patient tolerated the procedure well without complications and was subsequently admitted for inpatient rehabilitation on (b)(6) 2010.
Additional Manufacturer Narrative
The devices were not returned for evaluation; therefore, devices analysis could not be performed.Per the operative report provided there was ¿significant polyethylene wear with lysis.The cup was in a slightly neutral position.The femoral component itself appeared stable.¿.With this information the clinical/medical investigation concluded that, the pain and instability are consistent with the report that the right hip would ¿come out with either deep bending or squatting.¿ as well, the intraoperative findings of ¿significant polyethylene wear with lysis may be consistent with the reported instability.However, with the information provided the clinical root cause of the significant polyethylene wear with lysis, pain and instability cannot be confirmed.The patient impact beyond the revision cannot be determined.No further clinical assessment is warranted at this time.A review of the production orders for the liner, femoral head and the screws did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.According to the information investigated it can be concluded, that this event is an isolated event since no other similar events were identified.In addition, no prior escalated actions related to these part numbers and failure mode were found, the failure mode and associated harm are covered in the risk document in which the risk level is still adequate and based on the lack of design/manufacturing related causes supported, a device history record review is not required for the shell and the femoral.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 that wear of the polyethylene, metal and ceramic articulating surfaces of acetabular components may occur.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, this has been identified as an adverse event.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 products failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include patient condition, friction or joint tightness.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: REF LNR 28X 58-60 20DG SZ G
• Common Device Name: 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: 16018574
• Report Number: 1020279-2022-05011
• Device Sequence Number: 6922079
• Product Code: LPH
• UDI-Device Identifier: 03596010232281
• UDI-Public: 03596010232281
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K932755
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2000
• Device Explanted Year: 2010
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/28/2023

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
• Operator of Device: Health Professional
• Device Model Number: 71742858
• Device Catalogue Number: 71742858
• Device Lot Number: 80704960
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/20/2022
• Supplement Date Received by Manufacturer: 06/23/2023
• Initial Report FDA Received Date: 12/20/2022
• Supplement Report FDA Received Date: 06/28/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PN: 71302804 / LOT: 00111700; PN: 71306115 / LOT: 90906180; PN: 71336525 / LOT: 90210120; PN: 71336525 / LOT: 90210596; PN: 71336525 / LOT: 90311436; PN: 740058 / LOT: 90903959
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 111 KG