MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 0 HOLE ACET SHELL 58MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

Catalog Number	71331858
Medical Device Problem Code	Biocompatibility (2886)
Health Effect - Clinical Codes	Pain (1994); Osteolysis (2377); Metal Related Pathology (4530)
Date of Event	11/09/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Event or Problem Description
It was reported that, a left primary tha surgery was performed on (b)(6) 2012, using r3 acetabular components, an oxinium femoral head, with a modular neck and smf stem.The patient then experienced progressive hip pain, on (b)(6) 2019 was diagnosed with high cobalt levels and on (b)(6) 2019 an mri showed osteolysis involving the left superior lateral acetabulum.Therefore, on (b)(6) 2022 a revision surgery was performed due to metallosis.During procedure dark stained fluid and metallosis of soft tissues was found with no permanent damage.An or3o dual mobility liner was implanted with a depuy femoral head and stem; since the removal of the smf stem was difficult, a depuy trochanteric plate and wires were also implanted.The patient tolerated the procedure well.
Additional Manufacturer Narrative
H3, h6: given the nature of the alleged incident, the devices could not be returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation stated that the reported pain, elevated metal ions and significant amount of dark stained fluid is consistent with the reported metallosis.However, with the information provided, the clinical root cause of the reported metallosis cannot be confirmed.All documents and images provided as of this date have been reviewed and considered and unless noted do not contribute to the clinical/medical investigation.The patient impact is the reported metallosis, revision and expected transient post-op convalescence period.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 of the shell and stem for their part numbers over the past 12 months and for their batch numbers based on historical data of the devices did not reveal similar events for the listed devices.A review of complaint history of the femoral head and modular neck revealed a similar event for the listed devices over the previous 12 months, but no similar events for the batches based on the historical data, this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the instructions for use documents for total hip systems revealed that although rare, metal sensitivity reactions and/or allergic reactions to foreign materials have been reported in patients following joint replacement, which have required device removal.This has been identified as an adverse event in primary and revision surgery.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.A historical review for the shell and femoral head concluded that there are no prior actions related to these products and event.However, previous actions for the modular neck and stem were identified.The following actions were taken: the occurrence rating was updated, the risk management plans were reviewed and updated, an improved in vitro fretting testing was stablished, the applicable surgical techniques were reviewed to include the instruction to "cleaning and drying before the impaction".It was determined that the benefits of using a recalled modular neck during a hip revision surgery to replace an implanted modular neck on a redapt modular stem that is remaining implanted outweigh the risks of not using a recalled modular neck.Containment action was created for the stem, which prevented distribution of product.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 implant corrosion, irregular implant interaction, abnormal motion over time or patient condition.Corrective and preventive actions were previously initiated.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.
Additional Manufacturer Narrative
G3: report source.Section h3, h6: given the nature of the alleged incident, the devices could not be returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation stated that the reported pain, elevated metal ions and significant amount of dark stained fluid is consistent with the reported metallosis.However, with the information provided, the clinical root cause of the reported metallosis cannot be confirmed.Nevertheless, fretting is a known occurrence with the smf modular neck configuration and is therefore a likely contributory factor to the reported event.The patient impact is the reported metallosis, revision and expected transient post-op convalescence period.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 of the shell and stem for their part numbers over the past 12 months and for their batch numbers based on historical data of the devices did not reveal similar events for the listed devices.A review of complaint history of the femoral head and modular neck revealed a similar event for the listed devices over the previous 12 months, but no similar events for the batches based on the historical data, this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the instructions for use documents for total hip systems revealed that although rare, metal sensitivity reactions and/or allergic reactions to foreign materials have been reported in patients following joint replacement, which have required device removal.This has been identified as an adverse event in primary and revision surgery.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.A historical review for the shell and femoral head concluded that there are no prior actions related to these products and event.However, previous actions for the modular neck and stem were identified.The following actions were taken: the occurrence rating was updated, the risk management plans were reviewed and updated, an improved in vitro fretting testing was stablished, the applicable surgical techniques were reviewed to include the instruction to "cleaning and drying before the impaction".It was determined that the benefits of using a recalled modular neck during a hip revision surgery to replace an implanted modular neck on a redapt modular stem that is remaining implanted outweigh the risks of not using a recalled modular neck.Containment action was created for the stem, which prevented distribution of product.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 implant corrosion, irregular implant interaction, fretting, abnormal motion over time or patient condition.Corrective and preventive actions were previously initiated.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 0 HOLE ACET SHELL 58MM
• Common Device Name: 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: 18234450
• Report Number: 1020279-2023-02354
• Device Sequence Number: 15199681
• Product Code: MBL
• UDI-Device Identifier: 03596010597625
• UDI-Public: 03596010597625
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P030022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/11/2024

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/20/2022
• Device Catalogue Number: 71331858
• Device Lot Number: 12HM11811
• 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: 11/04/2023
• Supplement Date Received by Manufacturer: 12/22/2023; 01/11/2024
• Initial Report FDA Received Date: 11/29/2023
• Supplement Report FDA Received Date: 12/28/2023; 01/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/20/2012
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0945-2017, Z-0946-2017
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 71343600/OXINIUM FEM HD 12/14 36 MM +0; 71352112/HIGH OFFSET NEUTRAL MODULAR NECK; 71352506/SMF STEM WITH STIKTITE SZ 6
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male