MAUDE Adverse Event Report: ENCORE MEDICAL L.P. FOUNDATION HIP; LINER, ACETABULAR, HOODED, NEUTRAL, 10°, HXL/FMP, 32MM ID, MP6

Catalog Number	932-32-250
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	01/16/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery - due to dislocation of the hip.
Additional Manufacturer Narrative
Corrected data: concomitant products: remove concomitant medical product: 400-03-321, lot 860b1072 that was reported on the initial medical device report, and add the following: 400-05-000, lot 886b1032, 400-04-320,lot 882b1012.The implant date was changed from (b)(6) 2016 to (b)(6) 2016.Manufacturer narrative: the reason for this revision surgery was the patient's hip dislocated.The previous surgery and the revision detailed in this investigation occurred over 4 months apart.There was no information submitted with this complaint about any patient activities, accidents, or medical contraindications that may have contributed to the dislocation.The healthcare professional indicated there was no delay in surgery and another suitable device was available for use.The revision surgery was completed as intended.The device was disposed of at the hospital and not made available to djo surgical for examination.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 were no non-conforming material reports (ncmrs) associated with the product that may have contributed to a dislocation.The device and its applicable concomitant devices were verified to have gone through acceptable sterilization processes and were within their respective expiration date at the time of use during the previous surgery.The customer complaint history of the reported device (s) 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 "dislocation of the hip".There were no findings during this investigation that indicate that the reported device (s) was the source or had a direct connection with the patient's dislocation.No other information was submitted with the complaint regarding any activities the patient was involved in that may have contributed to the reported event.There are multiple factors that may contribute to an event; these are outside of the control of djo surgical.Inventory containment is not required as there are no indications of a product or process issue affecting implant safety or effectiveness.

• Brand Name: FOUNDATION HIP
• Common Device Name: LINER, ACETABULAR, HOODED, NEUTRAL, 10°, HXL/FMP, 32MM ID, MP6
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd.; austin TX 78758 5445
• MDR Report Key: 6312992
• Report Number: 1644408-2017-00051
• Device Sequence Number: 682130
• Product Code: LPH
• UDI-Device Identifier: 00888912100038
• UDI-Public: (01)00888912100038
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K072154
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/29/2017

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: 01/31/2017
• Device Catalogue Number: 932-32-250
• Device Lot Number: 724F1001
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/16/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/08/2017
• Supplement Report FDA Received Date: 03/29/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 400-03-321,LOT 860B1072
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 59 YR
• Patient Weight: 73