MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD BHR ACETLR CUP HAP 56MM W/ IMPTR; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 74120156

Device Problems Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problems Failure of Implant (1924); Pain (1994); Toxicity (2333); Injury (2348); Reaction (2414); No Known Impact Or Consequence To Patient (2692)

Event Date 11/15/2016

Event Type  Injury  

Manufacturer Narrative

Initial reporter fda report number:.(b)(6).

Event Description

Patient had a revision of left hip due to adverse tissue reaction from mom implant.Patient had increased hip pain, elevated ion levles and positive mire.Initial surgery in 2009.

Manufacturer Narrative

It was reported that left hip revision surgery was performed.During the revision, the bhr cup, hemi head and modular sleeve were removed.The synergy stem remained implanted.As of today, device return and additional information has been requested for this complaint but has not become available.In the absence of the actual devices, the production records were reviewed for the devices reportedly involved in this incident.The available medical documents were reviewed.The patient has significant comorbidities, including obesity, lower back and knee issues.In (b)(6) 2016, an mri was performed to evaluate left hip pain, and evidence of an adverse tissue reaction was found.Also, the patient¿s cobalt and chrome levels were noted to be elevated.The revision op report noted blackened tissue at the trunnion and evidence of trunnionosis, as well as some stained tissue consistent with adverse tissue reaction, which was debrided.The reported intraoperative findings of trunnionosis, stained tissue, avn and elevated cocr levels may be consistent with findings associated with metal debris.However, the root cause of the reported reactions/events noted in the legal claim cannot be confirmed.All the released devices involved met manufacturing specifications at the time of production.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.Correctiomfr site: correct information.

• Brand Name: BHR ACETLR CUP HAP 56MM W/ IMPTR
• 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: 6165658
• MDR Text Key: 62079760
• Report Number: 3005975929-2016-00057
• 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: health professional,user faci
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2013
• Device Catalogue Number: 74120156
• Device Lot Number: 096012
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/07/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 71306615/SYN POR FEM COMP SZ 15/09JM09810; 74222100/MODULAR SLEEVE -4MM 12/14/08LW19878; HEMI HEAD#74122550, LOT#08HW18420; HEMI HEAD#(B)(4), LOT#08HW18420
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 54 YR