MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 3 HOLE ACET SHELL 50MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

Catalog Number 71335550

Device Problem Biocompatibility (2886)

Patient Problems Discomfort (2330); Metal Related Pathology (4530)

Event Date 11/11/2021

Event Type  Injury  

Event Description

It was reported that, after a plaintiff underwent a right tha surgery on (b)(6) 2009, due to degenerative osteoarthritis, they developed hip pain that threatened mobility and had elevated cobalt levels in serum.A revision surgery was performed on (b)(6) 2021, in which blackish fluid and trunnionosis was found.All acetabular and femoral head components were exchanged for a redapt shell and oxinium s+n implants.No other complications were reported.

Manufacturer Narrative

H10: internal complaint reference: (b)(4).

Manufacturer Narrative

H3, h6: the devices were not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that, the reported pain, elevated serum cobalt, blackish fluid, and metal debris may be consistent with trunnionosis; however, the source of the reported reactions cannot be confirmed, and it cannot be concluded that the reported clinical reactions were associated with a mal performance of the implant.The patient impact is the reported pain, elevated cobalt, pseudotumor, trunnionosis, and revision.A review of the production orders did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.For all the devices, a review of complaint history for the part number over the past 12 months and for the batch number based on historical data of the device did not reveal similar events for the listed device.A review of the instructions for use documents for total hip systems revealed in warnings and precautions that the patient should be advised to report any pain and unusual incidences.Besides, in the adverse events in primary and revision surgery section it is mentioned 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.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 irregular implant interaction or abnormal motion over time.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: R3 3 HOLE ACET SHELL 50MM
• Type of Device: 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: 18119611
• MDR Text Key: 327929324
• Report Number: 1020279-2023-02209
• Device Sequence Number: 1
• Product Code: MBL
• UDI-Device Identifier: 03596010598233
• UDI-Public: 03596010598233
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K211176
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/06/2018
• Device Catalogue Number: 71335550
• Device Lot Number: 08GM04990
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/05/2024
• Date Device Manufactured: 07/08/2008
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: EMP 11 STEM PRIMARY SO, LOT#:09HM08394; EMP11 SLV MED CONE1 SPOUT, LOT#:07GAB0019A; HEMI HEAD 38MM, LOT#: 08JW19021; MODULAR SLEEVE -4MM 12/14, LOT#:08GW17829; R3 38MM ID US COCR LNR 50MM, LOT#:09BW22124
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 61 YR
• Patient Sex: Male