MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD ACETLR CUP HAP; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 74120158

Device Problems Insufficient Information (3190); Appropriate Term/Code Not Available (3191)

Patient Problems Debris, Bone Shedding (1803); Failure of Implant (1924); Injury (2348); Test Result (2695)

Event Date 12/26/2018

Event Type  Injury  

Event Description

It was reported a left hip revision due to failed system and trunnionosis.

Manufacturer Narrative

It was reported that left hip revision surgery was performed.During the revision, the bhr cup, hemi head, modular sleeve and synergy stem were removed.As no device batch numbers were provided for investigation, a manufacturing record review could not be performed.If more information is received, this investigation will be reopened.The available medical documents were reviewed.The revision operative notes report; ¿we then excised the trochanteric bursa, elevated the gluteus medius and minimus off the capsule, took down the piriformis and external rotators.There was a grayish fluid that came out of this.The pathologist called back and said there was no acute inflammation.- there was damage to the trunnion.¿ no metal ions were presented for review for this complaint.The impact to the patient beyond the surgery and recovery cannot be determined.Based on the clinical information provided, of the ¿grayish fluid¿ and the damage to the trunnion, may be consistent with a reaction to metal debris.However, the source and the root cause cannot be determined with the available documentation.Further, it cannot be concluded that the reported clinical reactions were associated with a mal-performance of the implant.Without return of the actual devices or further information we cannot further investigate or confirm the details supplied in this complaint, and our investigation remains inconclusive.If the products or additional information become available in the future, this case will be reopened.No preventative or corrective action has been initiated as a result of this investigation.

Manufacturer Narrative

It was reported that left hip revision surgery was performed.During the revision, the cup, hemi head, modular sleeve and stem removed.As of today, the implanted devices, all of which were used in treatment, and additional information have been requested for this complaint but have not become available.A review of the complaint history for the cup, hemi head, stem and sleeve was performed using batch numbers in search of similar recurring reports for the products during their lifetimes.No other similar complaints were identified for the cup, stem and hemi head.Similar complaints have been identified for the modular sleeve and this failure will continue to be monitored.In the absence of the actual devices, the production records were reviewed for the devices reportedly involved in this incident.Review of manufacturing records did not reveal any waivers, concessions, manufacturing or material abnormalities that could have contributed to this issue.Review of the product ifu found adequate warnings and precautions in relation to the alleged failure modes.A risk management review was performed.No additional risks were identified as result of the reported event.No further actions are required at this time.The available medical documents were reviewed.It cannot be determined to what extent the patient¿s comorbidities had on his pain and clinical status as well as the vertical orientation of the acetabulum.The reported pain, elevated cobalt and chromium levels along with radiological findings of mild edema and osteolysis of the left acetabulum as well as intraoperative findings of grayish fluid along the joint capsule, necrotic synovium and damage noted to the trunnion may be consistent with findings of metal debris and trunnionosis.However, changes in position of the acetabular component could also accelerate wear and lead to metal debris.Without the supporting analysis of the explanted components, the root cause of the vertical position of the acetabular component, metal debris and trunnionosis 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.Without return of the actual devices or further information we cannot further investigate or confirm the details supplied in this complaint, and our investigation remains inconclusive.If the products or additional information become available in the future, this case will.

Manufacturer Narrative

Udi and test results added.

• Brand Name: ACETLR CUP HAP
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house; spa park; leamington spa CV31 3HL; UK CV31 3HL
• MDR Report Key: 9183967
• MDR Text Key: 162371120
• Report Number: 3005975929-2019-00358
• Device Sequence Number: 1
• Product Code: NXT
• Combination Product (y/n): N
• PMA/PMN Number: P040033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/19/2020

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 Expiration Date: 05/31/2013
• Device Catalogue Number: 74120158
• Device Lot Number: 088009
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/27/2019
• Initial Date FDA Received: 10/14/2019
• Supplement Dates Manufacturer Received: 09/27/2019; 09/27/2019; 09/27/2019
• Supplement Dates FDA Received: 12/10/2019; 02/11/2020; 08/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: HEAD 74122550, LOT 08JW19088; HEAD 74122550, LOT UNKNOWN; SLEEVE 74222200, LOT 08JW19088; SLEEVE 74222200, LOT UNKNOWN; STEM 71306716, LOT UNKNOWN; STEM 71309016, BATCH 08HM11201A
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR