MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 20 DEG XLPE ACET LNR 36MM X 54MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	71335754
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Hematoma (1884); Infiltration into Tissue (1931); Inflammation (1932); Pain (1994); Swelling/ Edema (4577)
Date of Event	09/19/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
*us legal* it was reported that after a left tha was performed on (b)(6) 2016, plaintiff experienced increasing pain, effusion on left hip, and hematoma on the hip.An irrigation and debridement of hematoma, and debridement of left trochanteric bursa was performed on (b)(6) 2019 to initially treat these adverse events.However, plaintiff continued having issues, including high cobalt levels on blood ((b)(6) 2019: cobalt 19 mcg/l).Due to this, a revision surgery was performed on (b)(6) 2019.During surgery all the s+n devices were explanted, and new devices were implanted.After the revision surgery, the plaintiff experienced multiple interventions including a second revision surgery and open reduction with internal fixation of left pelvis fracture, however since there is no information about the manufacturer for all devices implanted on the first revision surgery, determination if some of the devices are from s+n cannot be concluded.A correlation between these events and our devices cannot be stablish.Plaintiff outcome is unknown.
Additional Manufacturer Narrative
H3, h6: 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 it is noted the patient had ¿left hip pain associated with metallosis,¿ the revision operative report did not note findings consistent with metallosis.The clinical root cause of the reported pain and elevated cobalt cannot be confirmed.It cannot be concluded the reported events were associated with a malperformance of the implant.The hematoma and trochanteric bursitis are known complications of hip surgery and are related to the surgery and not the implant.The inferior pubic rami fracture and femoral shaft fracture are noted to be associated with the first revision and are not associated with the ceramic head; it should be noted the manufacturer of the head is unknown.The patient impact beyond the revisions and postop convalescence period cannot be determined; however, it is noted at her 1-year follow-up, ¿patient reports she is improving with her strength, endurance, and overall health." 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, material in use or patient reaction.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.
Additional Manufacturer Narrative
B6: relevant tests/laboratory data, including dates and b7: other relevant history, including preexisting medical conditions.Section h3, h6: the device was not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that, although it is noted the patient had ¿left hip pain associated with metallosis,¿ the revision operative report did not note findings consistent with metallosis.The clinical root cause of the reported pain and elevated cobalt cannot be confirmed.It cannot be concluded the reported events were associated with a malperformance of the implant.The hematoma and trochanteric bursitis are known complications of hip surgery and are related to the surgery and not the implant.The inferior pubic rami fracture and femoral shaft fracture are noted to be associated with the first revision and are not associated with the ceramic head; it should be noted the manufacturer of the head is unknown.The patient impact beyond the revisions and postop convalescence period cannot be determined; however, it is noted at her 1-year follow-up, ¿patient reports she is improving with her strength, endurance, and overall health.¿ a review of the production order did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history revealed similar events for the listed device over the previous 24 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 in warnings and precautions that the patient should be advised to report any pain and unusual incidences.Also it is noted in the adverse events in primary and revision surgery section that although rare, metal sensitivity reactions have been reported in patients following joint replacement.A review of the risk management file 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 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.With the results of this investigation the root cause of this event could not be determined.Factors that could contribute to the reported event include traumatic injury, joint tightness and/or patient condition.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.We consider this investigation closed.

• Brand Name: R3 20 DEG XLPE ACET LNR 36MM X 54MM
• 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: 12638956
• Report Number: 1020279-2021-07577
• Device Sequence Number: 8191849
• Product Code: JDI
• UDI-Device Identifier: 03596010598349
• UDI-Public: 03596010598349
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K113848
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/23/2023

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: 03/29/2026
• Device Model Number: 71335754
• Device Catalogue Number: 71335754
• Device Lot Number: 16CM22606
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/21/2021
• Supplement Date Received by Manufacturer: 11/19/2021; 02/22/2023
• Initial Report FDA Received Date: 10/15/2021
• Supplement Report FDA Received Date: 11/22/2021; 02/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2016
• 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: 72 YR
• Patient Sex: Female