MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD RESURFACING FEMORAL HEAD 54MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Model Number 74121154

Device Problem Break (1069)

Patient Problem Fall (1848)

Event Date 11/10/2021

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference (b)(4).

Event Description

It was reported that, after a tha was performed on an unspecified date, the patient fell and a unkn birmingham hip resurfacing (bhr) cup (unkn type) and unkn birmingham hip resurfacing (bhr) head broke.It is unknown how this adverse event was solved.Current health status of patient is unknown.

Manufacturer Narrative

H10.Additional information in h6 (added a code in health effect - impact code).Internal reference number: (b)(4).H11.Corrected information in b2.Internal reference number: (b)(4).

Event Description

It was reported that, after a bhr resurfacing construct had been implanted on (b)(6) 2021, the patient fell and experienced the breakage of an acetabular cup hap size 52/60 and a resurfacing femoral head 54mm.This incident was solved by conducting a revision surgery on (b)(6) 2021.Current health status of patient is unknown.

Manufacturer Narrative

H3, h6: it was reported that after a tha was performed on an unspecified date, the patient fell resulting in a broken bhr head and cup.It is unknown how this adverse event was solved.The current health status of the patient is unknown.As of today, the implanted devices, all of which were used in treatment, and additional information has been requested for this complaint but has not become available.Without definitive lot numbers, a complete complaint history review cannot be performed for the devices involved.As no device batch numbers were provided for investigation, a manufacturing record review, device labelling and ifu review could not be performed.All the devices would have met manufacturing specifications at the time of production.If more information is received, this investigation will be reopened.A risk management review was performed.No additional risks were identified as result of the reported event.The alleged failure modes and associated risks have been anticipated within the risk file and the anticipated risk level is still adequate.Without the requested clinical information or the device, a thorough medical investigation cannot be rendered nor can the root cause of the reported failure be determined.However, we cannot rule out the reported fall as a likely contributory factor.The impact to the patient beyond that which has already been reported cannot be confirmed nor concluded.Without return of the actual devices or further information we cannot further investigate or confirm the reported complaint.The investigation remains inconclusive, and a definitive root cause cannot be determined.Additionally, specific factors known to contribute to the alleged fault cannot be provided due to the insufficient information.If the products or additional information become available in the future, this case will be reopened.Based on the results of this investigation, the need for corrective or preventative action is not indicated.

Manufacturer Narrative

H10: additional information in d4, d9 and h4.

Manufacturer Narrative

H3, h6: a bhr head (74121154, 20bw12827) and bhr cup (74120160, 20lw00004) were received for investigation following hip revision surgery.The devices were used in treatment.A review of the historical complaints data for the bhr head was performed.Using batch numbers to evaluate patterns of repeated failures or defects over the lifetime of the product and using part numbers and the reported failure modes to evaluate patterns of repeated failures or defects in a timeframe prior 12 months as of the complaint aware date.No other complaints were identified to involve this batch.No other similar complaints were identified for the part number and the reported/related failure mode.This will continue to be monitored.The production records were reviewed for the devices 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 result of the reported event.The alleged failure modes and associated risks have been anticipated within the risk file and the anticipated risk level is still adequate.A review of historic quality escalations related to the products and similar complaint events was performed.Following the review, no prior applicable escalation actions were identified.Visual inspection was carried out on the returned device.When the device were received, the head and the cup were stuck together, with foreign material in between.The device was separated using an ultrasonic bath.Once separated no visible damage was noted on the bhr head or cup.Wear analysis was performed to review linear wear on the bearing surface of the bhr head and bhr cup.Wear was low and a wear patch could not be identified on the head or the cup.The device was in vivo for 0.23 years.The foreign material was examined and analysed.The elements presented in the material closely match with the compositions of bone cement.It is unknown when the foreign material became present on the bearing surface.The available medical documents were reviewed.It was reported the patient fell and experienced a breakage of the acetabular cup and a resurfacing femoral head.The product evaluation noted, the head and the cup were stuck together with foreign material in between and once separated no visible damage was noted on the bhr head or cup.As of the date of this medical investigation, the requested clinical documentation has not been provided; however, we cannot rule out the reported fall as a likely contributory factor to the revision, with no breakage of the devices observed.The impact to the patient beyond the reported revision cannot be confirmed nor concluded.Based on the information provided and the returned device we cannot confirm the reported complaint.A probable root cause for the reported failure is the patient¿s fall.No preventative or corrective action has been initiated as a result of this investigation.

• Brand Name: RESURFACING FEMORAL HEAD 54MM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house, spa park; leamington spa warwickshire CV31 3HL; UK CV31 3HL
• Manufacturer (Section G): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house, spa park; leamington spa warwickshire CV31 3HL; UK CV31 3HL
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 12893124
• MDR Text Key: 281404684
• Report Number: 3005975929-2021-00544
• Device Sequence Number: 1
• Product Code: NXT
• UDI-Device Identifier: 03596010502803
• UDI-Public: 03596010502803
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: P040033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 12/16/2022

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 74121154
• Device Catalogue Number: 74121154
• Device Lot Number: 20BW12827
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/10/2021
• Initial Date FDA Received: 11/30/2021
• Supplement Dates Manufacturer Received: 03/11/2022; 03/03/2022; 10/13/2022; 12/14/2022
• Supplement Dates FDA Received: 03/15/2022; 03/20/2022; 10/13/2022; 12/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 51 YR
• Patient Sex: Male