MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD FEMORAL HEAD 48MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number	74123148
Medical Device Problem Codes	Biocompatibility (2886); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Metal Related Pathology (4530); Medical device site infection (4845)
Date of Event	08/10/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after the plaintiff underwent a left hip metal-on-metal bhr tha performed on (b)(6) 2010, the patient started to feel stiffness and pain.An mri scan indicated fluid and was consistent with metallosis.A left revision surgery was performed on (b)(6) 2022, in which a cloudy cystic fluid was found in and about the hip joint, with hypertrophied synovitis.No gross loosening of acetabular component was noticed.A conversion to tha was performed.The femoral head was removed and replaced for amis size 4_pfemoral component with 48 mm outer diameter dual mobility liner and a size 28_ s(- 3.5 mm)delta ceramic head.The acetabular component was retained.Nearly 4 weeks following the left hip revision and conversion to total hip arthroplasty, the patient had been doing very well until he began noticing pain and some swelling with some erythema in and around the incision, and some area of fluctuance.An additional revision surgery was performed on (b)(6) 2022, in order to remove medacta 48 mm outer diameter dual mobility liner with 28 mm s (-3.5 mm) delta ceramic head and replace them for medacta 48 mm outer diameter dual mobility liner with 28 mm s (-3.5 mm) delta ceramic head.A gross purulent exudate of fluid was noticed.And infection extended directly to joint area.There was some fibrinolytic debris in and around the joint and residual implants.The acetabular component was retained.This was debrided and irrigated thoroughly.The current health status of the patient is unknown.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).This complaint was opened by smith+nephew to document a reported patient complication that includes reference to the use of a smith+nephew product without evidence of a specific product problem.The reported complication relates to known inherent procedural risks that are appropriately documented in our risk files.Smith+nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.Smith+nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture.Based on our review of all currently available information, we are unable to confirm a relationship between the reported event and the device or identify a definitive root cause.However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are conservatively submitting this report in accordance with applicable regulations.If additional information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required.
Additional Manufacturer Narrative
H3,h6: as of today, the implanted devices, all of which were used in treatment have not been returned for evaluation.Without a definitive batch number, a complete review of the historical complaints data cannot be performed for the alleged devices.A review of historical complaints data was performed using the part numbers and the reported failure modes to evaluate patterns of repeated failures or defects.Similar complaints have been identified for the head.Similar complaints have been identified for cup.This failure will continue to be monitored via routine trending.As no device batch numbers were provided for investigation, manufacturing record review could not be performed.If more information is received, this investigation will be reopened.The review of the most recent ifu found adequate warnings and precautions in relation to the alleged failure modes.A risk management review was performed.The alleged failure modes and associated risks have been anticipated within the risk file and the anticipated risk level is still adequate.No further actions are required at this time.A review of historic escalation actions related to the products and similar complaint events was performed.Following the review, no prior applicable escalation actions were identified.The available medical documents were reviewed.The reported stiffness, pain, rare scattered microscopic metal fragments with some associated foreign body giant cell reaction are consistent with alval.Although the clinical root cause of the reported events cannot be definitively confirmed, the lateral and anteverted acetabular component can accelerate wear of the components and lead to the microscopic metal fragments and foreign body giant cell reaction.It should be noted the revision operative report did not note metallosis.Second revision: there is a definitive clinical route cause.The reported pain, swelling, erythema, and gross purulent exudate is consistent with the reported infection.However, the cause of the infection cannot be definitively confirmed.A chronic latent infection cannot be ruled out, as a possible contributing factor to the infection.As a large amount of cloudy fluid was noted within the previous revision 4-weeks prior.As well an acute infection is possible.A causal relationship between the infection and the implant cannot be concluded.A definitive root cause cannot be determined.Specific factors known to contribute to the alleged metallosis are excessive physical activity levels, unreasonable stress on replacement system, excessive patient weight, trauma to the joint replacement, loosening of components may increase production of wear particles, accelerate damage to the bone.Additonally, insufficient care of the surgical wound, incorrect and/or insufficient use of prophylactic antibiotics, patient smoking and patient compromised immune system and might contribute to the reported infection.Should the devices or additional information be received, the complaint will be reopened.Based on this investigation, the need for corrective and preventative actions is not indicated.

• Brand Name: FEMORAL HEAD 48MM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house, spa park; leamington spa warwickshire CV31 3HL; UK CV31 3HL
• Manufacturer (Section G): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house, spa park; leamington spa warwickshire CV31 3HL; UK CV31 3HL
• Manufacturer Contact: holly topping ; 1450 brooks rd.; memphis, TN 38116 ; 5123913905
• MDR Report Key: 21977979
• Report Number: 3005975929-2025-00037
• Device Sequence Number: 9188774
• Product Code: NXT
• UDI-Device Identifier: 03596010552426
• UDI-Public: 3596010552426
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P040033
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Consumer,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/12/2025

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
• Operator of Device: Health Professional
• Device Catalogue Number: 74123148
• Device Lot Number: UNKNOWN
• 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: 04/14/2025
• Supplement Date Received by Manufacturer: 06/06/2025
• Initial Report FDA Received Date: 05/07/2025
• Supplement Report FDA Received Date: 06/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 60 YR
• Patient Sex: Male