MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 3 HOLE ACET SHELL 56MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/CERAMIC/METAL,

Model Number	71335556
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Metal Related Pathology (4530); Nodule (4551)
Date of Event	07/02/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal reference number: (b)(4).
Event or Problem Description
''(b)(6) legal'': it was reported that after a r3 tha construct was implanted on (b)(6) 2008 the plaintiff experienced elevated metal ion levels on blood and pseudotumor.A revision surgery was performed on (b)(6) 2019 to treat these adverse events.During the surgery, a huge amount of brownish-black fluid was found on the hip.Additionally, grayish-black tissue in a large portion of the hip was found, and a pseudotumor was removed around the acetabulum and femoral portion on the hip.Microscopy study of the tissue removed showed tissue necrosis, fibrosis, chronic inflammation, with a good foreign body histiocyte reaction.Patient outcome is unknown.
Additional Manufacturer Narrative
The device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, although alval was suspected, the pathology report did not confirm.The elevated metal ion levels and intraoperative findings of blackish/brownish liquid, black gray caseous fabrics, and pseudotumor along with the synovial tissue fragments that show necrosis, fibrosis, chronic inflammation and histiocytic reaction to foreign body may be consistent with an adverse reaction to metal debris.However, based on the information provided, the clinical root cause of the clinical reactions cannot be confirmed.It cannot be concluded that the clinical reactions were associated with a malperformance of the implant.The patient impact beyond the revision cannot be determined.No further clinical assessment is warranted at this time.A review of complaint history did not reveal additional complaints for the listed batch.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of the risk management file and instructions for use documents revealed this failure mode was previously identified.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Possible causes could include but are not limited to traumatic injury, joint tightness, friction or wear.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.Should the device 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: R3 3 HOLE ACET SHELL 56MM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/CERAMIC/METAL,
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 12532643
• Report Number: 1020279-2021-07176
• Device Sequence Number: 16497408
• Product Code: MRA
• UDI-Device Identifier: 03596010598264
• UDI-Public: 03596010598264
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K070756
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2019
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/28/2021

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: 11/03/2017
• Device Model Number: 71335556
• Device Catalogue Number: 71335556
• Device Lot Number: 07LM04180
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/03/2021
• Supplement Date Received by Manufacturer: 10/27/2021
• Initial Report FDA Received Date: 09/27/2021
• Supplement Report FDA Received Date: 10/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MODULAR SLEEVE +4MM 12/14/07KW14071; SYN POR HO FEM COM SZ 18/ 02JM02565; MODULAR SLEEVE +4MM 12/14/07KW14071; SYN POR HO FEM COM SZ 18/ 02JM02565
• Outcome Attributed to Adverse Event: Required Intervention