MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKN FEM HEAD MEMPHIS OX; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

Catalog Number UNKNOWN

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

Patient Problems Scar Tissue (2060); Muscle/Tendon Damage (4532)

Event Date 03/01/2023

Event Type  Injury  

Manufacturer Narrative

Complaint reference number: (b)(4).

Event Description

It was reported that the plaintiff underwent a revision surgery on (b)(6) 2023 due to iliopsoas tendinitis/bursitis recalcitrant to conservative treatments.During the revision, a moderate amount of scar tissue was found along the anterior aspect of the acetabulum, and it was debrided.The was still some mild impingement from the iliopsoas, therefore a tenotomy/bursectomy was performed.The surgeon decided to replace the poly liner and the oxinium femoral head, and to retain the primary cup and femoral component.Before the revision surgery, the patient underwent a therapeutic target injection which reportedly provided her with near resolution of her symptoms, but only lasted for a period.The patient was transferred to the recovery room in stable condition.

Event Description

It was reported that the plaintiff underwent a right revision surgery on (b)(6) 2023 due to iliopsoas tendinitis/bursitis recalcitrant to conservative treatments.During the revision, a moderate amount of scar tissue was found along the anterior aspect of the acetabulum, and it was debrided.The was still some mild impingement from the iliopsoas, therefore a tenotomy/bursectomy was performed.The surgeon decided to replace the poly liner and the oxinium femoral head, and to retain the primary cup and femoral component.The patient was transferred to the recovery room in stable condition.Before the revision surgery, the patient underwent a therapeutic target injection which reportedly provided her with near resolution of her symptoms, but only lasted for a period.The plaintiff later underwent an open bursectomy/scar excision and tenotomy of the iliopsoas.The primary right hip surgery was performed on (b)(6) 2010.

Manufacturer Narrative

H3, h6: the devices were not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that all documents provided as of this date do not contribute to the investigation.The patient's history of ehlers-danlos syndrome cannot be ruled out as a contributing factor to the patients clinical status.The recurrent anterior hip/groin pain may be consistent with the iliopsoas tendonitis/ bursitis, moderate amount of scar tissue and/or the impingement from the iliopsoas.It cannot be concluded the reported events were associated with a mal performance of the implants or implants' failure.The patient impact beyond the revision cannot be determined with the information provided.No further clinical assessment is warranted at this time.For the femoral head and the liner, devices specific identifiers were not provided.Therefore, an evaluation of the manufacturing records, complaint history review, instructions for use, risk management file and prior actions review could not be performed.For the anthology stem and acetabular shell, a review of the production orders did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.Also, a review of complaint history for the part numbers over the past 12 months and for the batch numbers based on historical data of the device did not reveal similar events for the listed devices.A review of the instructions for use documents for knee systems provides complete guidelines of indications, contraindications, warnings and precautions and possible adverse effects that may occur preoperative, during surgery or post operative.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 reason to suspect that the products failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include post-operative healing issue, adverse reaction and/or patient condition.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.

• Brand Name: UNKN FEM HEAD MEMPHIS OX
• 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: 16928302
• MDR Text Key: 315170282
• Report Number: 1020279-2023-01044
• Device Sequence Number: 1
• Product Code: MBL
• Combination Product (y/n): N
• Reporter Country Code: US
• 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
• Report Date: 06/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/07/2023
• Was Device Evaluated by Manufacturer?: No
• 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: 71335552/R3 3 HOLE ACET SHELL 52MM; 71356105/ANTHOLOGY HO POROUS SZ 5; UNKN R3 LINER CERAMIC POLY
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR
• Patient Sex: Female