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 Problem Appropriate Term/Code Not Available (3191)

Patient Problems Failure of Implant (1924); Pain (1994)

Event Date 03/12/2015

Event Type  Injury  

Event Description

It was reported the patient developed pain in his left hip.Various tests performed.Mri showed large pseudotumor.Revision surgery performed.

Manufacturer Narrative

It was reported that left hip revision surgery was performed due to pain and a pseudotumor.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 known 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.The available medical documents were reviewed.It was reported that a left hip revision was done 6 years post tha due to a failed total hip arthroplasty and pseudotumor.During a pre-implantation office visit the patient requested birmingham resurfacing arthroplasty.A left hip x-ray showed significant cystic changes, complete joint space loss, flattening of the femoral head and increased sclerosis.He was informed by his physician that it could be attempted, but he was quite concerned about the size of the cyst that the patient had in the superior aspect of his femoral head.The implantation report indicates there was a large superior cyst and large inferior cyst.Six years post implantation he presented to the e.R.With flu like symptoms including fevers and chills and pain in the left hip.Subsequently, the patient was admitted with sepsis, rule out left septic hip versus uti versus viral etiology.He was also diagnosed with acute kidney injury.A left hip aspiration was positive for staphylococcus aureus and cobalt and chromium joint fluid levels were 776.0 g/l and 115.4g/l respectively.Three days following the aspiration which showed mssa, a revision was completed leaving the stem in situ.A mri and the intraoperative report indicated a pseudotumor over the lateral aspect of the greater trochanter.There was mild corrosion around the junction of the taper and the head.The histopathology tissue sample¿s gross examination describes red to grey tissue fragments.It should be noted that bhr is contraindicated for patients with cyst of the femoral head >1cm.The reported pain, elevated cobalt and chromium levels and the noted intraoperative findings of pseudotumor and corrosion are consistent with findings associated with metallosis.As well as the histopathological findings of stained tissue and inflammation.However, without the supporting lab/pathology results, imaging, and/or the analysis of the explanted components, the root cause of the reported pain, elevated cobalt and chromium levels, pseudotumor and adverse tissue reaction cannot be confirmed, and it cannot be concluded that the reported reactions were associated with a mal-performance of the implant.The origin of the mssa in the synovial fluid of the hip joint is highly likely of an exogenous nature and there is no evidence that our product contributed to the infection.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: 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: 6173370
• MDR Text Key: 62335270
• Report Number: 3005975929-2016-00066
• 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
• Report Date: 06/06/2019

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: 08/31/2013
• Device Catalogue Number: 74120156
• Device Lot Number: 092173
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/13/2016
• Initial Date FDA Received: 12/14/2016
• Supplement Dates Manufacturer Received: Not provided; 12/13/2016
• Supplement Dates FDA Received: 04/10/2017; 06/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: HEMI HEAD#74122550, LOT # 08JW18811; MODULAR SLEEVE#74222100 LOT # 08EW16956; STEM#71306115, LOT # 09BM12683; HEMI HEAD#74122550, LOT#08JW18811; MODULAR SLEEVE#74222100 LOT#08EW16956; STEM#71306115, LOT#09BM12683
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 57 YR