MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 0 DEG XLPE ACET LNR 36MM X 64MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	71332764
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erythema (1840); Failure of Implant (1924); Unspecified Infection (1930); Pain (1994)
Date of Event	10/09/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference (b)(4).Initial reporter postal code: (b)(6).
Event or Problem Description
It was reported that a patient presented to the hospital with worsening thigh pain and erythema after a revision surgery of the left hip performed 13 days ago.The patient underwent a second revision surgery of the left hip on (b)(6) 2021 to exchange an oxinium fem hd 12/14 36 mm +0 and an r3 0 deg xlpe acet lnr 36mm x 64mm due to infection.Extensive infection was noted during surgery.Patient current health status remains unknown.
Event or Problem Description
It was reported that a patient presented to the hospital with worsening thigh pain and erythema after a revision surgery of the left hip performed 13 days ago.The patient underwent a second revision surgery of the left hip on (b)(6) 2021 to exchange an oxinium fem hd 12/14 36 mm +0 and an r3 0 deg xlpe acet lnr 36mm x 64mm due to infection.Extensive infection was noted during surgery.Patient current health status remains unknown.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).Initial reporter postal code: 2605.
Additional Manufacturer Narrative
H3, h6: the device was not returned for evaluation and the reported event could not be confirmed.The contribution of the device to the reported event could not be corroborated.The clinical/medical investigation concluded that, per complaint details, the patient required a head and liner exchange due to pain, erythema and extensive infection approximately 13 days post-left tha revision.It was communicated that the requested documentation was not available.Reportedly, the root cause of the revision was an infection; however, without the requested clinical documentation, the source/root cause of the infection could not be fully assessed or concluded.The patient impact beyond the reported symptoms and subsequent revision could not be determined as the patient status remains unknown.No further medical investigation could be rendered at this time.Should clinically relevant documentation/information become available, the clinical/medical task may be re-evaluated.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 complaint history did not reveal similar events for the listed device.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.The instructions for use documents revealed this failure mode was previously identified.A review of the sterilization records revealed the batch was sterilized within normal parameters.A historical review concluded that there are no prior actions related to this product and event.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 contamination, patient reaction, and post-operative healing issue.Based on this investigation, the need for corrective action is not indicated.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.

• Brand Name: R3 0 DEG XLPE ACET LNR 36MM X 64MM
• 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: 12714135
• Report Number: 1020279-2021-07712
• Device Sequence Number: 4560170
• Product Code: JDI
• UDI-Device Identifier: 03596010598042
• UDI-Public: 03596010598042
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K113848
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/28/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/02/2025
• Device Model Number: 71332764
• Device Catalogue Number: 71332764
• Device Lot Number: 15LM04430
• 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: 10/09/2021
• Supplement Date Received by Manufacturer: 10/09/2021; 01/21/2022
• Initial Report FDA Received Date: 10/28/2021
• Supplement Report FDA Received Date: 11/08/2021; 01/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/05/2015
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other
• Patient Age: 61 YR
• Patient Sex: Male