MAUDE Adverse Event Report: ENCORE MEDICAL L.P. CONSTRAINED LINER; LINER, ACETABULAR, FMP CONSTRAINED 28XMP6

Model Number	436-28-006
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/16/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reason for this revision surgery was reported as dislodged acetabular liner.The previous surgery and the revision detailed in this investigation occurred over 5 months and 1 week apart.Initial or prolonged hospitalization was required.The healthcare professional indicated there was a serious risk to the patient.There was no delay in surgery and another suitable device was available for use.The revision surgery was completed as intended.The device was returned to manufacturer and device evaluation anticipated, but not yet begun in djo surgical.A review of the implant device history records (dhr) shows that the reported components used in the previous surgery met design and manufacturing requirements.There was a nonconformance in the main part #436-28-006, liner, acetabular, fmp constrained 28xmp6 which documents that out of 10 parts lot, 1 part was scrapped due to wrong work offset.All other items in the lot were met with the design, fit and function requirements.The device and its applicable concomitant devices were within their respective expiration dates at the time of use during the previous surgery.Customer complaint history of the reported devices showed no present trends or on-going issues that are in need of review.The root cause of this complaint was a revision surgery due to dislodged acetabular liner.There were no findings during this investigation that indicate that the reported device was the source or had a direct connection with the patient's event.Agent has clearly mentioned that "the ring and/or the acetabular liner dislodged and broke." it seems that the event might have possibly occurred due to excessive loading, patient noncompliance with medical instructions, inadequate soft tissue support, poor bone density, patient activities or trauma.No additional information was submitted with the complaint regarding pre-existing conditions of the patient or any patient activities that may have contributed to the event and hence a definitive root cause cannot be determined.There are no indications of a product or process issue affecting implant safety or effectiveness.
Event or Problem Description
Second revision surgery - the ring or the acetabular liner dislodged and broke.

• Brand Name: CONSTRAINED LINER
• Common Device Name: LINER, ACETABULAR, FMP CONSTRAINED 28XMP6
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin, tx 78758-5445
• MDR Report Key: 9056632
• Report Number: 1644408-2019-00877
• Device Sequence Number: 16640224
• Product Code: KWZ
• UDI-Device Identifier: 00888912085694
• UDI-Public: (01)00888912085694
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K023794
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/13/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/02/2022
• Device Model Number: 436-28-006
• Device Catalogue Number: 436-28-006
• Device Lot Number: 498C1011
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/16/2019
• Initial Report FDA Received Date: 09/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other; Required Intervention
• Patient Age: 66 YR
• Patient Weight: 64