MAUDE Adverse Event Report: SMITH & NEPHEW, INC. 40MM OXINIUM MODULAR HEAD; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

Model Number 71342340

Device Problems Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Failure of Implant (1924); Joint Dislocation (2374); Ambulation Difficulties (2544); Joint Laxity (4526)

Event Date 10/08/2021

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference (b)(4).

Event Description

(b)(6).It was reported that, after a first revision surgery was performed on the plaintiff¿s right hip on (b)(6) 2017, the plaintiff experienced instability and a joint dislocation.A revision surgery was performed on (b)(6) 2018 to treat this adverse event.During this procedure, the 40mm oxinium modular head was explanted.A blackened tissue was noticeable intraoperatively due to a significant wear present on this explanted head.The plaintiff¿s outcome is unknown.

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, the root cause of the dislocation cannot be confirmed; however, the patient¿s body movement (turning while putting dishes away), cannot be ruled out as a contributory factor.The reported pain, squeaking and intraoperative findings of blackened tissue maybe consistent with the reported ¿significant wear seen on the head.¿ the clinical root cause of the significant wear on the head cannot be confirmed.However, without the implantation and pre-revision x-rays to determine initial implant anatomical placement and any micro-motion over time, this cannot be ruled out as a contributory factor to the reported issue.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 did not reveal additional complaints for the listed batch.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, patient condition, traumatic injury, patient anatomy or abnormal loading of limb.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.

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, with the information provided the root cause of the dislocation cannot be confirmed; however, the patient¿s body movement (turning while putting dishes away), cannot be ruled out as a contributory factor.The reported pain, squeaking and intraoperative findings of blackened tissue maybe consistent with the reported ¿significant wear seen on the head.¿ the clinical root cause of the significant wear on the head cannot be confirmed.However, without the implantation and pre-revision x-rays to determine initial implant anatomical placement and any micro-motion over time, this cannot be ruled out as a contributory factor to the reported issue.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, but no similar events for the batch, this failure mode will be monitored for future complaints for any necessary corrective actions.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 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, patient condition, traumatic injury, patient anatomy or abnormal loading of limb.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.

• Brand Name: 40MM OXINIUM MODULAR HEAD
• 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: 12720454
• MDR Text Key: 279056814
• Report Number: 1020279-2021-07727
• Device Sequence Number: 1
• Product Code: MBL
• UDI-Device Identifier: 00885556112410
• UDI-Public: 00885556112410
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093363
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 71342340
• Device Catalogue Number: 71342340
• Device Lot Number: 17BM11392
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/21/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/15/2017
• 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: 71306614-SYN POR FEM COMP SZ 14; 71344248-TITANIUM MODULAR HEAD SLV 12/14 TPR +4; 71306614-SYN POR FEM COMP SZ 14; 71344248-TITANIUM MODULAR HEAD SLV 12/14 TPR +4
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 67 YR
• Patient Sex: Female