MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKN FEMORAL HEAD IMPL; PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL

Catalog Number UNKNOWN

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

Patient Problems Bone Fracture(s) (1870); Inflammation (1932); Muscle/Tendon Damage (4532)

Event Date 08/19/2021

Event Type  Injury  

Event Description

It was reported that on literature review ""excellent mid-term outcomes with a hemispheric titanium porous-coated acetabular component for total hip arthroplasty: 7¿10 year follow-up"", 2 patients suffered from a complication after undergoing a primary tha using the r3 acetabular system.One patient had a periprosthetic fracture at the greater trochanter, which was treated non-surgically.The other patient underwent a 2 stage revision surgery at postoperative day #966 to treat bursitis and disruption of the abductor mechanim.The outcome of the patients is unknown.No further information is available.

Manufacturer Narrative

Internal complaint reference: (b)(4).Yeroushalmi, d., singh, v., maher, n., gabor, j.A., zuckerman, j.D., & schwarzkopf, r.(2021).Excellent mid-term outcomes with a hemispheric titanium porous-coated acetabular component for total hip arthroplasty: 7¿10 year follow-up.Hip international, 11207000211040181.Doi: doi.Org/10.1177/11207000211040181.

Manufacturer Narrative

The device was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, per subsequent e-mail, no further information will be provided.Subsequently, without clinically relevant patient-specific supporting documentation, a thorough medical investigation could not be performed.The images provided in the article have been interpreted within the text; therefore, no further analysis of the images are required.The root cause and/or patient outcome beyond that which was documented in the article could not be confirmed nor concluded; therefore, no further medical assessment is warranted at this time.Should any additional relevant patient information be provided, this case would be re-assessed.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Factors and/or some potential probable causes that could contribute to the reported event have been identified as overuse or excessive pressure on the joint, injury, infection and/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: UNKN FEMORAL HEAD IMPL
• Type of Device: PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, 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: 13770433
• MDR Text Key: 287193465
• Report Number: 1020279-2022-01168
• Device Sequence Number: 1
• Product Code: JDG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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