MAUDE Adverse Event Report: R3 48MM ID INTL COCR LINER 60MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/CERAMIC/METAL,

Catalog Number 71335860

Device Problem Device Appears to Trigger Rejection (1524)

Patient Problems Metal Related Pathology (4530); Swelling/ Edema (4577)

Event Date 08/24/2017

Event Type  Injury  

Manufacturer Narrative

Internal reference number: (b)(4).

Event Description

''(b)(6) legal'': bilateral patient.It was reported that, after a primary r3-tha construct had been implanted on the plaintiff¿s right hip on (b)(6) 2009, the plaintiff experienced an alval reaction consistent with metallosis, elevated metal ion levels in blood, swelling and the presence of a brownish colored pseudotumor.A revision surgery was performed on (b)(6) 2017 to treat this adverse event; the 48 mm diameter bhr modular head and r3 acetabular liner co-cr were explanted.Surgery was completed without any complications.

Manufacturer Narrative

H3, h6: it was reported that a right hip revision surgery was performed.Both the head and r3 liner used in treatment were explanted but were not returned for evaluation.The other devices used in treatment were not returned for evaluation since they remain implanted in the patient.Additional information has been requested for this complaint but has not become available.A review of the complaint history for the modular head, r3 liner, r3 shell and modular sleeve was performed using batch numbers in search of similar recurring reports for the products during their lifetimes.No other similar complaints have been identified for the modular head, or r3 shell.Similar complaints have been identified for the r3 liner and sleeve.However, as the devices are no longer sold, no action is to be taken.On account of the fact devices reportedly involved in this incident were not returned for evaluation, the relevant production records were reviewed.All released devices involved met manufacturing specifications upon release for distribution.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.No further actions are required at this time.The available medical documents were reviewed.The reported elevated metal ion levels in blood and swelling, along with the intraoperative findings of brownish mass, greyish tissue, cloudy fluid, and oxidation may be consistent with findings associated with metallosis.However, based on the information provided, the clinical root cause of the reported clinical reactions cannot be confirmed.It cannot be concluded that the clinical reactions were associated with a malperformance of the implant or implant failure.The patient impact beyond the revision and expected transient post-operative convalescence period cannot be determined.Without the return of the actual product involved or further product information, our investigation could not proceed and remains inconclusive.A definitive root cause cannot be determined, and we are unable to determine specific factors known to contribute to the alleged fault.Should the device or additional information be received, the complaint will be reopened.Based on this investigation, the need for corrective and preventative actions is not indicated.No further investigation is warranted for this complaint.

• Brand Name: R3 48MM ID INTL COCR LINER 60MM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/CERAMIC/METAL,
• MDR Report Key: 12532432
• MDR Text Key: 273320959
• Report Number: 3005975929-2021-00433
• Device Sequence Number: 1
• Product Code: MRA
• UDI-Device Identifier: 03596010596147
• UDI-Public: 3596010596147
• Combination Product (y/n): N
• PMA/PMN Number: P150030
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/04/2021

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 Expiration Date: 07/30/2018
• Device Catalogue Number: 71335860
• Device Lot Number: 08GW18031
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/03/2021
• Initial Date FDA Received: 09/27/2021
• Supplement Dates Manufacturer Received: 11/04/2021
• Supplement Dates FDA Received: 11/04/2021
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ANTHOLOGY SO POROUS SZ 11/07KM23172; MODULAR SLEEVE +4MM 12/14/07KW14071; R3 3 HOLE HA CTD ACET SHELL 60MM/08JM08533A; ANTHOLOGY SO POROUS SZ 11/07KM23172; MODULAR SLEEVE +4MM 12/14/07KW14071; R3 3 HOLE HA CTD ACET SHELL 60MM/08JM08533A
• Patient Outcome(s): Required Intervention