MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 20 DEG XLPE ACET LNR 32MM X 48MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	71337648
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Failure of Implant (1924); Joint Dislocation (2374)
Date of Event	08/01/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal reference number: (b)(4).
Event or Problem Description
It was reported that the patient suffered from left hip mechanical loosening after having a thr surgery on (b)(6) 2011.As noted by the surgeon, the liner has likely spun out of the acetabular component.During the revision surgery performed on (b)(6) 2017, the surgeon implanted a biomet acetabular system and an oxinium femoral component.The current state of health of the patient is unknown.
Additional Manufacturer Narrative
Additional information: b5, b7.H3, h6: the devices were not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that considering the left hip in the two provided images, one is undated and the other appears dated prior to the left total hip arthroplasty revisions in (b)(6) 2017 is accurate.The shell appears consistent between the two images but cannot confirm the reported displaced poly as its not visible in either image.With the information provided a clinical root cause for the reported displaced poly cannot be definitively concluded.However, the left knee/thigh wound infection cannot be ruled out as a possible contributing factor to the reported mechanical loosening.The patient impact was the revision.A review of the production orders did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.For the liner and the shell, 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.For the stem, a review of complaint history revealed a similar event for the listed device over the previous 12 months, but no similar events for the batch based on the historical data, this failure mode will be monitored for future complaints for any necessary corrective actions.For the femoral head, a review of complaint history revealed similar events for the listed device over the previous 12 months, but no similar events for the batch 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 dislocation has been identified in warnings and precautions, that may result from improper selection of the neck length and cup, stem positioning, muscle looseness and/or malpositioning of components.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 evidence to conclude that the product failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include traumatic injury, patient condition or abnormal loading of limb.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.
Event or Problem Description
It was reported that the patient suffered from left hip mechanical loosening after having a thr surgery on (b)(6) 2011.As noted by the surgeon, the liner has likely spun out of the acetabular component.During the revision surgery performed on (b)(6) 2017, the surgeon implanted a biomet acetabular system and an oxinium femoral component.The current state of health of the patient is unknown.

• Brand Name: R3 20 DEG XLPE ACET LNR 32MM X 48MM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• 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: 19399042
• Report Number: 1020279-2024-01008
• Device Sequence Number: 15216194
• Product Code: JDI
• UDI-Device Identifier: 03596010598479
• UDI-Public: 03596010598479
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K113848
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2024

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?: No
• Device Expiration Date: 08/10/2021
• Device Catalogue Number: 71337648
• Device Lot Number: 11HM06438
• 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: 04/29/2024
• Supplement Date Received by Manufacturer: 06/25/2024
• Initial Report FDA Received Date: 05/26/2024
• Supplement Report FDA Received Date: 06/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/10/2011
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ANTHOLOGY HO POROUS SZ 6 / 71356106; OXINIUM FEM HD 12/14 32MM +0 / 71343200; R3 3 HOLE ACET SHELL MM48 / 71335548
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 57 YR
• Patient Sex: Female