MAUDE Adverse Event Report: REDAPT FULLY POROUS SHELL 58MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	71354234
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	10/28/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
(b)(6) legal.Bilateral patient.It was reported that, after a primary revision surgery had been performed on the plaintiff¿s right hip on (b)(6) 2019, the plaintiff experienced loosening of the acetabular shell implant due to loss of osteointegration.A second revision surgery was performed on (b)(6) 2020 to treat this adverse event; the, redapt pt fully porous shell 58mm, 12/14 taper femoral head 36mm oxinium and redapt cemented liner xlpe 36mmx58mm were explanted.The plaintiff was taken to recovery room in good condition.
Additional Manufacturer Narrative
H3, h6: the device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, after a right tha revision (b)(6) 2019, the patient had a 2nd revision 15 months later.The revision operative report noted ¿clear synovial fluid.We still take cultures, even if we have no suspicion of infection.The cup that is completely protrusion and is completely inverted.The cup moves on its own so there is no osseointegration currently and there is a complete unsealing of this patella.¿ conclusion: the loosening of the acetabular shell is consistent with the reported loss of osteointegration, as well as the ¿completely protrusion and completely inverted cup.¿ however, without the implantation and pre-revision x-rays, the initial anatomical placement of the implants cannot be confirmed.It cannot be concluded the reported events and subsequent revision were associated with a malperformance of the implant or implant failure.The patient impact beyond the revision and expected transient post-op convalescence period cannot be determined.A review of complaint history did not reveal additional complaints for the listed batch.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of the risk management file and instructions for use documents revealed this failure mode was previously identified.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Factors and/or some potential probable causes that could contribute to the reported event have been identified as abnormal motion over time, bone degeneration, fit/sizing, lack of ingrowth and/or traumatic injury.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.Should the device or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.

• Brand Name: REDAPT FULLY POROUS SHELL 58MM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• MDR Report Key: 12519828
• Report Number: 1020279-2021-07094
• Device Sequence Number: 1113652
• Product Code: LPH
• UDI-Device Identifier: 00885556321447
• UDI-Public: 00885556321447
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K150790
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/02/2021

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
• Operator of Device: Health Professional
• Device Model Number: 71354234
• Device Catalogue Number: 71354234
• Device Lot Number: 16MM03964
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/01/2021
• Supplement Date Received by Manufacturer: 10/18/2021
• Initial Report FDA Received Date: 09/23/2021
• Supplement Report FDA Received Date: 11/02/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/07/2016
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other; Required Intervention
• Patient Age: 47 YR