MAUDE Adverse Event Report: EXACTECH, INC. NV CROWN CUP CLSTR HOLE 52MM GROUP 2; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	NV CROWN CUP CLSTR HOLE 52MM GROUP 2
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Osteolysis (2377)
Date of Event	04/23/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: p-series pf plasma h/o collarless sz 2 12/14 (cat# 118-41-02); nv gxl lnr, lipped 32mm id group 2 cups (cat# 132-32-52); 12/14 zirconia head 32mm +0mm neck (cat# 148-32-00); platelet rich plasma kit with spray tips (cat# 620-00-02); accelerate conc.Sys rep by 620-12-02 (cat# 620-11-02).Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported, patient was being revised due to pain and significant osteolysis.Prophylactic posterior column plating and then removed the novation cup and gxl liner.
Additional Manufacturer Narrative
After further review of additional information received.(h3) as reported, patient was being revised due to pain and significant osteolysis.Prophylactic posterior column plating and then removed the novation cup and gxl liner.Upon review of the available information, there is no evidence that this is a device related problem and there is no allegation against the device.This cause of the reported event is most likely patient conditions, however; cannot be confirmed as the device was not returned for evaluation.

• Brand Name: NV CROWN CUP CLSTR HOLE 52MM GROUP 2
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 11805288
• Report Number: 1038671-2021-00223
• Device Sequence Number: 19703357
• Product Code: JDI
• UDI-Device Identifier: 10885862037015
• UDI-Public: 10885862037015
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: 180-01-52
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/17/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/04/2013
• Device Model Number: NV CROWN CUP CLSTR HOLE 52MM GROUP 2
• Device Catalogue Number: 180-01-52
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/23/2021
• Supplement Date Received by Manufacturer: 06/02/2021
• Initial Report FDA Received Date: 05/11/2021
• Supplement Report FDA Received Date: 06/17/2021
• 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: Required Intervention; Disability