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

Model Number 71335556

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Metal Related Pathology (4530); Nodule (4551)

Event Date 07/02/2019

Event Type  Injury  

Manufacturer Narrative

Internal reference number: (b)(4).

Event 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.

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
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/CERAMIC/METAL,
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 12532643
• MDR Text Key: 273329107
• Report Number: 1020279-2021-07176
• Device Sequence Number: 1
• Product Code: MRA
• UDI-Device Identifier: 03596010598264
• UDI-Public: 03596010598264
• Combination Product (y/n): N
• PMA/PMN Number: K070756
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 10/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 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
• Patient Outcome(s): Required Intervention