MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD BHR ACETABULAR CUP 52MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Model Number 74120152

Device Problems Malposition of Device (2616); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Toxicity (2333); Reaction (2414); Test Result (2695); No Code Available (3191)

Event Date 01/10/2017

Event Type  Injury  

Event Description

It was reported that a re-revision due to severe pain, elevated metal levels, malpositioning of cup and adverse tissue reactions was performed.Prior revision of resurfacing femoral head component only previously reported via submission 3005975929-2017-00371.Cup inserted (b)(6)2009 during original resurfacing procedure.

Manufacturer Narrative

Through a legal claim, it was reported that left hip revision surgery was performed due to severe pain, elevated metal levels, malpositioning of cup and adverse tissue reactions.Two previous revisions were performed for this patient.The first revision removed the bhr head implanted on (b)(6) 2009 (b)(4).The second revision removed the hemi head and sleeve implanted on (b)(6) 2011 (b)(4) due to recurrent dislocations.This investigation centres on the 3rd revision, where the original bhr cup implanted on (b)(6) 2009 was revised, along with the hemi head and sleeve inserted on (b)(6) 2011.The femoral stem implanted on (b)(6) 2011 remained implanted.As of today, device return and additional information has been requested for this revision complaint but has not become available.No device part and lot details were provided for the hemi head and sleeve to facilitate production record review.However, in the absence of the actual devices, the production records were reviewed for the bhr cup and femoral stem devices reportedly involved in this incident.Device history record review confirmed that all these released parts met specifications applicable at the time of production.The supplied medical documents were reviewed.According to the provided revision report of the third revision, the patient had severe left hip pain, had rising metal ion levels, an mri showed altr (adverse local tissue reaction) and the acetabular component was with mal-positioning.There was no loosening, but synovitis and some acetabular wall defects.The cup was implanted at the initial surgery and remained in-vivo during the following two revisions ((b)(4) and (b)(4)).The cup position was described as good in the previous revision reports.As no x-rays were provided, the reported mal-positioning, respectively a change of position with time cannot be assessed.Without the explants available, it remains unclear whether the reported mal-position led to an increased amount of wear.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 a third hip revision surgery was performed.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.Without definitive part/lot numbers a complete complaint history review cannot be performed for all of the devices involved.A review of the complaint history for the bhr cup & stem was performed using batch numbers in search of similar recurring reports for the products during their lifetimes.No other similar complaints were identified.In the absence of the actual devices, the production records were reviewed for the known devices reportedly involved in this incident.All the released devices involved met manufacturing specifications at the time of production.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 a result of the reported event.The available medical documents were reviewed.It should be noted metal debris was noted on the femoral plate during prior revision.It is unknown if the increased abduction angle of the cetabular component led to accelerated wear and the synovitis noted intraoperatively.The pain, elevated metal ions and inflammation are associated with adverse tissue reaction, however, without the supporting lab/pathology results or imaging, the root cause 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 revision 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 be reopened.No preventative or corrective action has been initiated as a result of this investigation.

• Brand Name: BHR ACETABULAR CUP 52MM
• 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: 6954032
• MDR Text Key: 89455269
• Report Number: 3005975929-2017-00373
• Device Sequence Number: 1
• Product Code: NXT
• UDI-Device Identifier: 03596010502575
• UDI-Public: 03596010502575
• Combination Product (y/n): N
• PMA/PMN Number: P040033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2013
• Device Model Number: 74120152
• Device Catalogue Number: 74120152
• Device Lot Number: 087572
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: FEMORAL STEM, # 71932817, LOT # 08GM06096.; HEMI HEAD, # 74122546, LOT # 08DW16733.; HEMI HEAD, # 74122546, LOT # UNKNOWN.; MODULAR SLEEVE, # 74222200, LOT # 10BW25771.; MODULAR SLEEVE, 74222300, LOT # UNKNOWN.; FEMORAL STEM, # 71932817, LOT # 08GM06096; HEMI HEAD, # 74122546, LOT # 08DW16733; MODULAR SLEEVE, # 74222200, LOT # 10BW25771
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 60 YR