MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 3 HOLE ACET SHELL 58MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/CERAMIC/METAL,

Model Number 71335558

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

Patient Problems Failure of Implant (1924); Necrosis (1971); Joint Dislocation (2374); Joint Laxity (4526); Metal Related Pathology (4530)

Event Date 10/22/2019

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference number: case(b)(4).

Event Description

It was reported that a second revision surgery was performed on the patients right hip on (b)(6) 2019 due to subsequent instability on the patient right hip.Among the intraoperative findings there some areas of devitalized or necrotic tissue from pre-existing pseudotumor.The patient outcome is unknown.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

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, in conclusion: the reported elevated cocr levels, and presence of a large pseudotumor, and soft tissue and muscle necrosis were observed intraoperatively during the revision of rt mom tha, which was in situ for 9 years.These intraoperative findings are consistent with findings associated with metal debris.The report of the patient having a ¿limited lumbar spine which affects his spinal pelvic motion and compounds the instability issues¿ and the cup orientation being ¿in more anteversion than ideal" cannot be ruled out as contributing factors of the subsequent multiple dislocations, which ultimately led to the 2nd revision.However, without x-ray images this cannot be confirmed.Therefore, the clinical root cause 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 beyond the pain, revision, and expected transient post-op convalescence period cannot be determined.No further clinical assessment is warranted at this time.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A complaint history review found related failures for the listed batch; this failure mode will be monitored for future complaints for any necessary corrective actions.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 not limited to fit/sizing issue, lifetime of device or patient condition.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 information: d3.

Event Description

It was reported that a second revision surgery was performed on the patient¿s right hip on (b)(6) 2019 due to subsequent instability on the patient right hip and anteversion of the acetabular cup.Before this intervention, the patient experienced 3 dislocations on the revised hip that required a closed reduction performed on (b)(6) 2019, (b)(6) 2019 and (b)(6) 2019.Among the second revision intraoperative findings, there were some areas of devitalized or necrotic tissue from pre-existing pseudotumor.The cup, liner and femoral head were explanted and replaced with a new cup and a constrained liner/femoral head.The patient¿s outcome is unknown.

Manufacturer Narrative

H3, h6: the device was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation reviewed the newly provided medical records, however, the previously conclusion remains valid; the reported elevated cocr levels, and presence of a large pseudotumor, and soft tissue and muscle necrosis were observed intraoperatively during the revision of rt mom tha, which was in situ for 9 years.These intraoperative findings are consistent with findings associated with metal debris.The report of the patient having a ¿limited lumbar spine which affects his spinal pelvic motion and compounds the instability issues¿ and the cup orientation being ¿in more anteversion than ideal" cannot be ruled out as contributing factors of the subsequent multiple dislocations, which ultimately led to the 2nd revision.However, without x-ray images this cannot be confirmed.Therefore, the clinical root cause 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 beyond the pain, revision, and expected transient post-op convalescence period cannot be determined.No further clinical assessment is warranted at this time.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 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 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 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.Possible causes could include but not limited to fit/sizing issue, lifetime of device or patient condition.The contribution of the device to the reported event could not be corroborated.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 58MM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/CERAMIC/METAL,
• 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: 11480068
• MDR Text Key: 239664822
• Report Number: 1020279-2021-02159
• Device Sequence Number: 1
• Product Code: MRA
• UDI-Device Identifier: 03596010598271
• UDI-Public: 03596010598271
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/14/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 04/02/2020
• Device Model Number: 71335558
• Device Catalogue Number: 71335558
• Device Lot Number: 10DM01171
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/18/2021
• Initial Date FDA Received: 03/15/2021
• Supplement Dates Manufacturer Received: 08/11/2021; 05/25/2022; 07/13/2022
• Supplement Dates FDA Received: 08/12/2021; 06/01/2022; 07/14/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/05/2010
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male