MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKN ANTHOLOGY HIP IMPL; PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL

Catalog Number UNKN01101100

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/31/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

On the literature article named "modular junction may be more problematic than bearing wear in metal-on-metal total hip arthroplasty", it was reported that, after an anthology stem had been implanted on 1 patient, 1 revision surgery was performed due to stem loosening.It is unknown which devices were explanted.The outcome of the patient is also 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.Without patient-specific surgical records and x-rays, further assessment of the reported events cannot be provided, and the root cause beyond those reported in the article cannot be concluded.The patient impact beyond the reported events cannot be determined.No further medical assessment could be rendered at this time.Should additional clinically relevant documentation become available the medical investigation task may be re-evaluated.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 but not limited to abnormal motion over time, bone degeneration, design of device, fit/sizing, lack of ingrowth, lifetime of device, and traumatic injury.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved or product information, 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 ANTHOLOGY HIP IMPL
• Type of Device: PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11815436
• MDR Text Key: 250303872
• Report Number: 1020279-2021-04117
• Device Sequence Number: 1
• Product Code: JDH
• Combination Product (y/n): N
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature,other,user
• Type of Report: Initial,Followup
• Report Date: 06/14/2021

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: Other
• Device Catalogue Number: UNKN01101100
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/26/2021
• Initial Date FDA Received: 05/12/2021
• Supplement Dates Manufacturer Received: 06/11/2021
• Supplement Dates FDA Received: 06/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKN BIRMINGHAM HIP MODULAR HEAD (BHMH) HEMI; UNKN BIRMINGHAM HIP MODULAR HEAD (BHMH) SLEEVED MO; UNKN BIRMINGHAM HIP RESURFACING (BHR) CUP (UNKN TY; UNKN BIRMINGHAM HIP MODULAR HEAD (BHMH) HEMI; UNKN BIRMINGHAM HIP MODULAR HEAD (BHMH) SLEEVED MO; UNKN BIRMINGHAM HIP RESURFACING (BHR) CUP (UNKN TY
• Patient Outcome(s): Required Intervention