MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD ACETABULAR CUP; ACETLR CUP HAP 58MM W/ IMPTR

Catalog Number 74120156

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

Patient Problems Abscess (1690); Bacterial Infection (1735); Loss of Range of Motion (2032); Toxicity (2333); Arthralgia (2355); Foreign Body In Patient (2687)

Event Type  Injury  

Event Description

In (b)(6) 2015 patient diagnosed with recurrent abscess and appropriate smear tests, laboratory tests and neurosurgical consultations were conducted.In (b)(6) 2015, mr.(b)(6) was re-admitted to the emergency and general surgery department of (b)(6).During his hospitalization, the anorectal abscess was incised and drained.Empirical antibiotic therapy was initiated.The client was recommended to take in specified medications and undergo further examinations.Subsequent laboratory tests indicated presence of bacteria susceptible or resistant to specific antibiotics which had a negative influence on the injured party's health status.In (b)(6) 2016, the client was admitted to the hospital emergency department of (b)(6), due to re-occurrence of severe pain in his right hip joint.Before hospitalisation the client was walking only with the use elbow crutches and suffered from painful and limited range of motion of his right hip joint for some time.The ultrasound scans of the hip and lower leg performed during his hospitalisation revealed fluid collection of 40 x 17 x 26 mm on the right side near the hip joint outline and approximately 30 mm in depth.Appropriate medical and photographic documentation was made.At the same time, diagnosis consisting in suspicion of metallosis - on the grounds of examinations conducted - was made.Thus, laboratory tests aiming at establishing cobalt and chromium levels were recommended.In addition, treatment of tibial tuberosity bursitis was initiated.The biochemical laboratory tests showed significantly exceeded blood level of cobalt.Following the revision of the bmhr components a further procedure occurred (b)(6) 2016 to replace poly pad of inserted acetabulum.

Manufacturer Narrative

Manufacturer Narrative

Additional information in concomitant medical products, device manufacture date.It was reported that right hip revision surgery was performed.During the revision, the bhr cup, bmhr head and bmhr stem were removed.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.All the released devices involved met manufacturing specifications at the time of production.No medical documentation or information was provided for investigation.The reported event cannot be assessed and a thorough medical assessment cannot be performed.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.

• Brand Name: ACETABULAR CUP
• Type of Device: ACETLR CUP HAP 58MM W/ IMPTR
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house; spa park; leamington spa CV31 3HL; UK CV31 3HL
• MDR Report Key: 5948708
• MDR Text Key: 54630562
• Report Number: 3005975929-2016-00007
• 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: foreign,other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/10/2019

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: Health Professional
• Device Expiration Date: 08/31/2016
• Device Catalogue Number: 74120156
• Device Lot Number: 11GW01438
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/02/2016
• Initial Date FDA Received: 09/14/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; 09/13/2016
• Supplement Dates FDA Received: 09/16/2016; 10/18/2016; 07/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: FEMORAL HEAD PART & LOT UNKNOWN; PART# 74431313, LOT# 08KW19563R; PART# 74432050, LOT# 11GW04106; FEMORAL HEAD PART & LOT UNKNOWN
• Patient Outcome(s): Hospitalization
• Patient Age: 56 YR